[c09aa8]: / clusters / 9knumclustersv2 / clust_203.txt

Download this file

180 lines (179 with data), 29.0 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
Patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* Parts A & C: patients with recurrent or refractory solid tumors, without central nervous system (CNS) tumors or known CNS metastases, are eligible; note: CNS imaging for patients without a known history of CNS disease is only required if clinically indicated\r\n* Part B: patients with relapsed or refractory neuroblastoma\r\n* Part B: patients with relapsed or refractory osteosarcoma\r\n* Part B: patients with relapsed or refractory rhabdomyosarcoma\r\n* Part B: patients with relapsed or refractory Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET)\r\n* Part B: patients with relapsed or refractory Hodgkin lymphoma\r\n* Part B: patients with relapsed or refractory non-Hodgkin lymphoma\r\n* Part B: patients with unresectable melanoma or metastatic melanoma or relapsed melanoma or refractory melanoma\r\n* Part B: Patients with relapsed or refractory neuroblastoma (MIBG evaluable disease without Response Evaluation Criteria in Solid Tumors [RECIST] measurable lesion)\r\n* Once the dose-escalation portion of Part A is completed, cohorts that are open concurrently for eligible patients (including Parts B and C and potential pharmacokinetic [PK] expansion cohorts) may be selected at the treating physicians discretion pending slot availability; in the event a disease group cohort in Part B is completed after the initial stage of Simons optimal two-stage design, for selected disease cohorts, a corresponding cohort in the same disease group for select disease types will be open in Part D:\r\n* Part D: Patients with relapsed or refractory neuroblastoma\r\n* Part D: Patients with relapsed or refractory osteosarcoma\r\n* Part D: Patients with relapsed or refractory rhabdomyosarcoma\r\n* Part D: Patients with relapsed or refractory Ewing sarcoma or peripheral PNET \r\n* Part D: Patients with relapsed or refractory non-Hodgkin lymphoma\r\n* Part D: Patients with relapsed or refractory neuroblastoma (MIBG evaluable disease without RECIST measurable lesion)\r\n* Part E: Patients with relapsed or refractory rhabdomyosarcoma\r\n* Part E: Patients with relapsed or refractory Ewing sarcoma or peripheral PNET
Part B: Patients with relapsed or refractory neuroblastoma
Part C: Patients with relapsed or refractory medulloblastoma or CNS PNET
Part D: Patients with relapsed or refractory rhabdomyosarcoma
Relapsed or refractory acute myelocytic leukemia (AML) with nucleophosmin- (NPM) mutations and no available therapies.
Relapsed or refractory mantle cell lymphoma (MCL) with no adequate therapies.
Confirmed diagnosis of a relapsed or refractory malignancy in of treatment groups:
Diagnosis of relapsed or refractory lymphoid malignancy for which there are no available therapies.
Pathologically confirmed relapsed or refractory lymphoma
Confirmed evidence of relapse/disease progression from immediately prior MM therapy or relapsed and refractory to the immediately prior treatment; relapsed and refractory disease is defined as those who are non-responsive (< minimal response) on salvage therapy or experience disease progression within days of last therapy in patients who have achieved an MR or better to previous therapy; relapsed disease is defined as previously treated myeloma that progresses and requires the initiation of salvage therapy but does not meet IMWG criteria for relapsed and refractory
Relapsed or refractory to the most recently received therapy.
All pts must have received prior lenalidomide therapy and been determined to be refractory, relapsed, or intolerant.
For Daratumumab + lenalidomide + dexamethasone (D-Rd) regimen: relapsed or refractory disease
Relapsed or refractory disease after at least prior regimen, defined using the Lugano classification
Patient must have disease that has either relapsed or is refractory to prior therap
Part D only: Patients diagnosed with CLL who are intolerant to, or have disease that is relapsed/refractory after, at least two prior therapies
Part F only: Patients with documented HTLV- infection and histologically or cytologically proven ATLL of any stage, and who are intolerant to, or have disease that is relapsed/refractory after, at least one prior therapy
The patient has confirmed relapsed or refractory MM
Previous treatment with nelarabine for relapsed or refractory disease
requiring treatment for relapsed or relapsed/refractory disease
AML relapsed or refractory to prior therapy, or ? years of age and not a candidate for other therapies Phase a:
Patients must have relapsed or refractory disease following at least two prior platinumcontaining chemotherapy regimens
Patients with T-cell lymphoma (untreated, relapsed or refractory) (Phase II)
Patients with previously untreated or relapsed/refractory disease will be eligible
Patients must have histologic evidence of relapsed or refractory B-cell ALL
Patient must have relapsed/refractory disease with an indication for treatment
Relapsed or relapsed/refractory disease
Relapsed or refractory B-precursor ALL defined as one of the following:
Relapsed or refractory disease after first or later salvage therapy
Relapsed or refractory after at least one prior treatment regimen
AML that is refractory to or relapsed after standard induction therapy.
Disease status defined as refractory to or relapsed after >= prior treatment lines.
Relapsed or refractory AML, who require salvage therapy
Relapsed and/or refractory disease on at least prior treatment regimen, as follows:\r\n* Aggressive B-cell lymphoma: relapsed after and/or refractory to at least prior doxorubicin-containing regimen\r\n* Indolent B-cell lymphoma: relapsed after and/or refractory to at least prior rituximab-containing regimen
Patients >= years of age with relapsed/refractory Ph-positive ALL.
Patients must have CD+ B cell malignancy with relapsed or refractory disease, defined as below:\r\n* Patients with chronic lymphocytic leukemia (CLL):\r\n** Refractory to or relapsed after at least prior chemo or chemoimmunotherapy (e.g. fludarabine, cyclophosphamide, rituximab [FCR], bendamustine plus rituximab [BR]) requiring further treatment \r\n** Refractory to or relapsed after at least prior biologic agent (e.g. ibrutinib, idelalisib, venetoclax, except a single agent anti-CD monoclonal antibody) requiring further treatment\r\n* Patients with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma [FL], marginal zone lymphoma [MZL], Waldenstrom macroglobulinemia [WM]):\r\n** Refractory or relapsed after at least lines of chemoimmunotherapy (including at least one course of anti-CD antibody)\r\n** Refractory or relapsed after at least prior biologic agent (e.g. lenalidomide, ibrutinib, idelalisib)\r\n** Patients must have measurable disease (for WM patients, measurable disease is demonstrable monoclonal paraprotein and bone marrow involvement)\r\n* Patients with diffuse large B cell lymphoma (DLBCL), transformed B cell lymphoma, or high grade B cell lymphoma:\r\n** Refractory to or relapsed after or more prior chemoimmunotherapies with at least one containing an anthracycline and CD directed therapy\r\n** Transplant ineligible\r\n** Biopsy proven relapsed disease\r\n* Patients with acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML) in lymphoid blast crisis or Burkitts lymphoma:\r\n** Refractory to at least prior induction chemotherapy\r\n** Relapsed after at least prior multiagent systemic chemotherapy that included induction and consolidation\r\n** Patients with Philadelphia chromosome-positive ALL must have failed a second generation tyrosine kinase inhibitor
Diagnosis of acute myeloid leukemia (AML) (other than acute promyelocytic leukemia [APL]) with refractory/relapsed disease; patients with relapsed/refractory high-risk ([intermediate- or higher by International Prognostic Scoring System [IPSS] and/or >= % blasts]). Myelodysplastic syndrome (MDS) will also be eligible. (Treatment approach for relapsed/refractory AML is very similar to that of high risk MDS)
Relapsed or refractory B-cell NHL, including
Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC. Prior use of cisplatin (or carboplatin) is permitted.
Patients must have relapsed or refractory cancers for which there is no known curative option
Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments.
Part A: Relapsed or refractory extracranial solid tumors and (Phase b expansion) relapsed or refractory extracranial solid tumors with molecular alterations, non-gene fusions;
Part C: Relapsed or refractory neuroblastoma;
Relapsed/refractory disease
with relapsed or refractory disease without established alternative therapy or
Relapsed, refractory, or recurrent malignancy; all solid tumor diagnoses will be eligible
All patients with histologically or cytologically confirmed relapsed or refractory AML (except acute promyelocytic leukemia); relapsed disease or refractory (refractory to a non-high-dose cytarabine-containing regimen only); receiving st, nd or rd salvage; any cytogenetic or molecular abnormality; patients with secondary AML (after prior myelodysplasia or therapy for other cancers) will be included
Patients must meet one of the following disease criteria within months of registration; salvage therapy is allowed between the patient meeting one of the below criterion and registration; patients will be considered eligible regardless of their current disease status (i.e. complete remission, partial remission, stable disease, progressive disease) unless otherwise noted below as long as one of the below criterion has been met within the previous months :\r\n* Relapsed/refractory Hodgkin lymphoma after autologous stem cell transplant (ASCT)\r\n* Relapsed/refractory Hodgkin lymphoma, deemed ineligible for ASCT due to refractory disease\r\n* Relapsed/refractory diffuse large B cell lymphoma after ASCT (history of transformed lymphoma is acceptable); disease must be in at least complete remission or partial remission with the use of salvage therapy before study treatment commences\r\n* Relapsed/refractory diffuse large B cell lymphoma, deemed ineligible for ASCT due to refractory disease (history of transformed lymphoma is acceptable); disease must be in at least complete remission or partial remission with the use of salvage therapy before study treatment commences\r\n* Relapsed/refractory T cell lymphoma relapsed after at least prior line of therapy\r\n* Relapsed/refractory follicular lymphoma relapsed after at least prior line of therapy\r\n* Relapsed/refractory mantle cell lymphoma relapsed after at least prior line of therapy\r\n* Relapsed/refractory small lymphocytic lymphoma/chronic lymphocytic leukemia relapsed after at least prior line of therapy\r\n* Relapsed/refractory non-Hodgkin lymphoma, if not specified above, relapsed after at least prior line of therapy
Relapsed/refractory lymphoma after CTL
Participants who are either refractory to or relapsed within days of receiving a regimen containing a cumulative dose of greater than or equal to (>/=) g/m^ of cytarabine
Refractory to or relapsed after at least prior treatment regimen
Patients with malignancy that is suspected or proven to have progressed, relapsed, or be persistent since progressive, relapsed or persistent malignancy documented since BMT
PHASE II COMPONENT: The population will be restricted to relapsed/refractory sarcomas
Must have relapsed or refractory acute lymphoblastic leukemia (ALL) or relapsed or refractory lymphoblastic lymphoma (LL). Refractory is defined as persistent disease after at least courses of chemotherapy.
Patients must have histologically confirmed relapsed/refractory or previously untreated mantle cell lymphoma (any stage)
Patients with previously treated B-cell ALL (relapsed and/or refractory after prior therapy)
Patients must have relapsed or refractory acute leukemias or high-risk MDS for which no standard therapies are anticipated to result in a durable remission
Relapsed/refractory disease that has failed conventional therapy and other therapies of higher priority
Relapsed or refractory to no more than course of a systemic therapy regimen and is incurable by either surgery or radiation.
Burkitts or Burkitt-like leukemia/lymphoma, either previously untreated, or relapsed/refractory, or human immunodeficiency virus (HIV)-related; patients HIV positive will be described and reported separately or relapsed/refractory acute lymphoblastic leukemia (ALL)
Patients who are not candidates for, intolerant, or relapsed/refractory to ruxolitinib
Refractory to or relapsed after at least prior treatment regimen
Relapsed/refractory MCL: Patient has relapsed and or refractory MCL and must have received at least one prior treatment regimen for their disease; patient with leukemia phase (peripheral blood involvement), leptomeningeal disease, cerebral spinal fluid (CSF) MCL, central nervous system (CNS) MCL, non-measurable disease, gastrointestinal (GI) MCL, or bone marrow (BM) MCL are also eligible
Relapsed/refractory MCL: Patients with bone marrow or gastrointestinal (GI) only involvement are acceptable
Relapsed/refractory MCL: The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patients health and survival, than of the MCL, within the subsequent months at the time of consent
Relapsed/refractory MCL: Prior treatment with ibrutinib
Relapsed or refractory AML
Relapsed or refractory to the most recently received therapy; refractory disease is defined as =< % response or progression during therapy or within days after completion
Relapsed/refractory to at least one prior standard systemic treatment regimen, but no more than .
Relapsed disease
Primarily refractory or relapsed disease
Relapsed ALL PATIENT CHARACTERISTICS:
Patients with relapsed/refractory CMML.
Refractory to or relapsed after at least prior treatment regimen
Pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) Acute Myeloid Leukemia (AML) (defined by World Health Organization (WHO) criteria) for which no further conventional therapy is suitable for the patient, or confirmed myelodysplastic syndrome defined according to WHO classification, with an International Prognostic Scoring System (IPSS) risk category of intermediate- or high risk, that is relapsed, refractory or intolerant to conventional therapy within weeks of registration.
Relapsed/refractory disease
The subject must have precursor B-cell or T-cell acute lymphoblastic leukemia. B-cell: relapsed or refractory after first or subsequent salvage therapy; or T-cell: relapsed or refractory with first remission duration less than or equal to months in first salvage; or relapsed or refractory after first or subsequent salvage therapy
Histological confirmation of relapsed or refractory AML after prior anti-leukemic therapy by WHO Classification
Patients with relapsed/refractory CLL defined as having received ? treatment regimens that included:
Phase I: Pathologically confirmed relapsed or refractory B cell lymphoma; must have relapsed after initial therapy; no restriction in number of prior lines of therapy
Phase II: Pathologically confirmed relapsed or refractory HL; no restriction in number of prior lines of therapy
Biopsy proven WM with relapsed/refractory symptomatic disease are eligible for\n enrollment.
Refractory or relapsed HL patients that are also candidates for ASCT
Medulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy; patients with pineoblastoma are eligible
* Phase (Part B): Patients with ALK+ relapsed or refractory neuroblastoma
* Phase (Part C): Patients with ALK+ relapsed or refractory ALCL (excluding patients with primary cutaneous ALCL)
Relapsed, refractory, or progressive disease following at least prior systemic therapies
Portion B: Histological confirmed relapsed or refractory CD positive NHL for which no curative therapy is available. Patients enrolled in the expansion cohort must have archival tissue available, sampled within months of study entry. The Expansion cohort includes patients with FL or DLBCL with relapsed or refractory disease.
Relapsed or refractory Richter syndrome and has received ? previous treatment for RS.
Phase expansion: Relapsed or refractory DLBCL
Relapsed or refractory pediatric B-cell ALL:
Must be relapsed or refractory after or prior therapies. For this protocol, relapsed is defined as progressive disease (PD) documented more than days after last dose; refractory is defined as documented absence of hematologic response or hematologic progression on or within days after last dose of prior therapy.
Relapsed or relapsed and refractory MM after receiving at least previous therapies, including an immunomodulator and bortezomib and had either no response or documented disease progression (according to IMWG criteria) to the most recent treatment regimen
T-ALL or T-LBL participants with relapsed/refractory disease.
Relapsed or refractory pediatric B-cell ALL.
For relapsed/refractory subjects only:
Relapsed following, or refractory to, previous ASCT
Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within months, and were refractory to their last treatment
Follicular low-grade NHL: either treatment nave (except for France) or relapsed or refractory following at least one prior treatment. In Part Dose Escalation only, in addition to follicular NHL, marginal zone B cell lymphomas: either treatment nave or relapsed or refractory following at least one prior treatment.
Male or female patients, ages years or older with pathologically confirmed relapsed or refractory B-cell lineage NHL who have failed or are intolerant to established therapy, or for whom no other treatment options are available. Refractory or relapsed B-cell NHL (per World health Organization [WHO] Classification system)
Must have a documented diagnosis of MM and have relapsed or relapsed-and-refractory disease. All patients must have relapsed after having achieved at least stable disease (SD) for at least cycle of treatment to at least prior regimen and then developed progressive disease (PD). Relapsed-and-refractory patients also have documented evidence of PD during or within days of completing last treatment
relapsed and/or refractory disease
Pathologically confirmed, relapsed or refractory acute myelogenous leukemia
Subject who has documented active relapsed or refractory disease requiring therapeutic intervention.
Treatment Naive MCL patients requiring treatment with no exposure to prior therapies. Relapsed/Refractory patients defined as disease relapsed or been refractory to ? prior therapies for MCL and requiring further treatment. Patient who discontinued any prior treatment for MCL for tolerability reasons can also be enrolled.
Subjects must have received prior treatment with a lenalidomide-containing regimen for at least consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within days of the last dose.
Relapsed or refractory with at least one (FL) or two (MCL), but not more than four, prior lines of antineoplastic regimens.
Relapsed, refractory or previously untreated CLL
For relapsed disease:
Patients with relapsed or refractory AML\r\n* Patients without a response after two cycles of a -day course of decitabine\r\n* Patients with primary refractory AML (persistent disease after standard induction with +) or relapsed AML\r\n* Patients who have relapsed post-allogeneic transplant
Documented relapsed, refractory or progressive disease after treatment with systemic therapy and must not be Rituximab-refractory.
Need of treatment for relapsed, progressed or refractory disease as assessed by the investigator.
Part I: Subjects must have relapsed or refractory B cell NHL
Dose Escalation: Patients with relapsed or refractory AML
Have active, relapsed or refractory Acute Myeloid Leukemia (AML). Active, relapsed or refractory AML is defined as either () primary induction failure (PIF) after or more cycles of chemotherapy, ( first early relapse after a remission duration of fewer than months, () relapse refractory to salvage combination chemotherapy containing high-dose AraC, and () second or subsequent relapse
Relapsed or refractory B-precursor ALL defined as one of the following:
Relapsed or refractory disease after first or later salvage therapy
Relapsed or refractory CLL patients must meet the following requirements:\r\n* Received at least prior therapy\r\n* Require treatment in the opinion of the investigator\r\n* Relapsed patients must have developed progressive disease following a response to a prior therapy\r\n* Refractory patients must have failed to respond or relapsed within months to the last prior therapy
Relapsed refractory disease after at least but not more than lines of previous systemic therapy
Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL
Active refractory or relapsed acute leukemia
Subject has relapsed/refractory disease with an indication for treatment
Relapsed or refractory disease
Patients with relapsed or refractory AML
Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL)
Disease that has relapsed or was refractory after prior chemo-immunotherapy
Histologically documented relapsed or refractory (defined as having relapsed within months to the previous treatment) follicular lymphoma grade I-IIIA
Diagnosis of Myelodysplastic syndrome (MDS) according to WHO classification with refractory anemia with excess blasts (subtype RAEB- or RAEB-), or considered high-risk by the Revised International Prognostic Scoring System (IPSS-R), that is recurrent or refractory, or the subject is intolerant to established therapy known to provide clinical benefit for their condition (i.e., subjects must not be candidates for regimens known to provide clinical benefit), according to the treating physician and with approval of the Medical Monitor. Phase /Part Expansion: Arm : Relapsed or refractory AML and age greater than or equal to years or any subject with AML regardless of age who has relapsed following a Bone marrow transplant (BMT). Arm : Relapsed or refractory AML and age < years, excluding subjects with AML who have relapsed following a BMT. Arm : Untreated AML and age greater than or equal to years that decline standard of care chemotherapy. Arm : Isocitrate dehydrogenase protein, (IDH)-mutated advanced hematologic malignancies not eligible for Arms to . Phase : Diagnosis of AML according to World Health Organization (WHO) criteria and disease relapsed or refractory as defined by:
Refractory to or relapsed after at least prior treatment regimen;
Relapsed or Relapsed/Refractory MM with progressive disease (PD) according to IMWG.
Patients must have relapsed or progressed after at least one prior therapy
B-cell CLL: Relapsed from or refractory to ? prior lines of treatment, ? of which must have contained rituximab
Relapsed or refractory B-ALL, defined as:
Relapsed or refractory AML
Must have histologically confirmed DLBCL that is relapsed or refractory to previous therapy.
Relapsed or refractory to hypomethylating agents
Relapsed/refractory disease failing >= prior therapies; an exception is patients with KS, where patients can be previously untreated, relapsed/refractory to one or more prior therapies, or intolerant of a prior therapy
Patients must have relapsed or refractory MCL
Patients with previously treated ALL (relapsed and/or refractory after prior therapy); patients with relapsed/refractory biphenotypic leukemia expressing the appropriate antigen (CD) are also eligible to participate; pediatric patients younger than may be considered with sponsor approval once the MTD has been established in the adult population
Subject must be either resistant to or intolerant of (ie., treatment failures) the last BCR PI and/or venetoclax. Resistant is defined as relapsed or refractory per
Relapsed, refractory, or progressive disease following at least prior systemic therapies
Adults with pathologically confirmed, relapsed or refractory acute myelogenous leukemia OR those and older who are not candidates for, or decline, conventional frontline chemotherapy
Patients must have relapsed or refractory disease following:
Relapsed/refractory MDS
Patients with relapsed/refractory AML regardless of cytogenetic risk
Patients with relapsed/refractory ALL
Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria, and have relapsed or become refractory to conventional therapy
Confirmed diagnosis of relapsed/refractory AML (WHO criteria) Refractory subjects, up to second consecutive salvage . Relapsed subjects including first and second relapse.
Adult patients must be relapsed or refractory to at least prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
Patient has relapsed or refractory disease and received at least one prior therapy.
Patients with relapsed /refractory AML, ALL, or MLL with rearrangement of the MLL gene, including q or PTD, are eligible for the expanded cohort:
Histologically confirmed relapsed or refractory FL (Grades , , or a) or relapsed or refractory DLBCL
B: Refractory or relapsed neuroblastoma
Relapsed/refractory, pathologically confirmed EBV+ lymphoid malignancy or lymphoproliferative disease
Participants must have relapsed or refractory cancer.
Part I: Patients with one of the following histologically- or cytologically-proven conditions: relapsed/refractory AML, relapsed/refractory MDS, or advanced CML in AP or BP (i.e., Acute Group patients).
Relapsed or refractory AML with poor prognostic features
Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within days of completing their last myeloma therapy
Previously treated relapsed or refractory B-cell iNHL
Diagnosis of relapsed or refractory chronic lymphocytic leukaemia.
Patients with relapsed/refractory AML regardless of cytogenetic risk
Patients with relapsed/refractory ALL
Patients with relapsed or persistent malignancy requiring immunosuppressive withdrawal or modulation (an example of this may be a patient who relapsed and was being treatment with DLI and then developed GvHD)
Relapsed or refractory to the most recently received therapy. Relapsed is defined as documented evidence of PD after achieving at least SD for ? cycle. Refractory disease is defined as ? % response (i.e., patients never achieved minimal response or better) or progression during therapy or within days after completion of therapy.
Expected chronic thrombocytopenia in patients with relapsed or refractory hematological malignancies or;
Relapsed/refractory disease within a prior radiation field
Confirmed relapsed/refractory diagnosis of select hematologic malignancies for which no standard/salvage therapies are available.
Subjects who have relapsed or refractory MDS.
Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL
Patients with a relapsed and/or refractory underlying hematologic malignancy
Disease Status: Refractory or first or multiple relapsed neuroblastoma, or medulloblastoma that has relapsed after, or is refractory to, a chemotherapy-containing treatment regimen.
Relapsed or is refractory to previous therapy, or
Relapsed/persistent malignancy
Relapsed/Refractory Cohorts: Pathologically confirmed relapsed or refractory (primary refractory and/or relapsed refractory) AML or confirmed intermediate, high, or very high risk MDS that is relapsed, refractory or intolerant to conventional therapy
Patients must have had evidence of having relapsed, progressed or become refractory to conventional therapy
Participants who are relapsed after or refractory to regimens containing venetoclax or other BCL inhibitors.
In the Dose Escalation Segment, patients who are refractory, relapsed, or unresponsive to standard treatment.
Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or refractory high-risk MDS (Myelodysplastic Syndrome) (Part B only) as defined by World Health Organization criteria who are not suitable for other established therapies.
Patients with relapsed or refractory disease with no available standard therapy