Clinical trial · Interventional
T-Cell-Depleted Allogeneic Stem Cell Transplantation After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
T-Cell Depleted, Reduced-Intensity Allogeneic Stem Cell Transplantation From Haploidentical Related Donors For Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Donor peripheral stem cell transplantation may be able to replace bone marrow and immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells before transplanting them and giving cyclosporine may prevent this from happening. PURPOSE: This phase I trial is studying the side effects of T-cell-depleted allogeneic stem cell transplantation after immunoablative induction chemotherapy and reduced-intensity transplantation conditioning (chemotherapy) in treating patients with hematologic malignancies.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| graft-versus-tumor induction therapy | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following hematologic malignancies:
* Acute myeloid leukemia (AML), meeting 1 of the following criteria:
* In first complete remission (CR1), meeting 1 of the following criteria:
* Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR), defined as 1 of the following:
* Complex karyotype \[≥ 3 abnormalities\]
* inv(3) or t(3;3)
* t(6;9)
* t(6;11)
* Monosomy 7
* Trisomy 8, alone or with an abnormality other than t(8;21), t(9;11), inv(16), or t(16;16)
* t(11;19) (q23;p13.1)
* Failed to achieve CR after primary induction chemotherapy
* Secondary AML
* In second or subsequent remission (CR2 or greater)
* Acute lymphoblastic leukemia, meeting 1 of the following criteria:
* In CR1, meeting 1 of the following criteria:
* Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, FISH, or PCR, defined as the following:
* Translocations involving 11q23, t(9;22), or bcr-abl rearrangement
* Failed to achieve CR after primary induction chemotherapy
* In CR2, if CR1 was \< 12 months
* In CR3 or greater
* Myelodysplastic syndromes (MDS)
* INT-2 or high-risk by International Prognostic Scoring System
* No MDS with Fanconi anemia
* Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:
* Accelerated phase with treatment failure after imatinib mesylate
* Blast phase
* Myeloproliferative disorders, meeting 1 of the following criteria:
* Agnogenic myeloid metaplasia with adverse-risk features, meeting at least 2 of the following criteria:
* Hemoglobin \< 10 g/dL or \> 10g/dL if transfusion-dependent
* WBC \< 4,000/mm\^3 OR \> 30,000/mm\^3 OR requires cytoreductive therapy to maintain WBC \< 30,000/mm\^3
* Abnormal cytogenetics, including +8, 12p-
* Polycythemia vera or essential thrombocythemia in transformation to secondary AML
* Myelodysplastic/myeloproliferative disease
* Chronic myelomonocytic leukemia
* Hodgkin's lymphoma or non-Hodgkin's lymphoma
* Refractory lymphoma with progressive disease during combination chemotherapy
* Relapse after OR ineligible for autologous stem cell transplantation (SCT)
* Chronic lymphocytic leukemia
* Treatment failure\* after fludarabine, chlorambucil, and at least 1 other salvage regimen
* Prolymphocytic leukemia (PLL), meeting 1 of the following criteria:
* T-PLL
* Treatment failure\* after alemtuzumab and at least 1 other regimen
* B-PLL
* Treatment failure\* after fludarabine and at least 1 other salvage regimen
* Multiple myeloma, meeting 1 of the following criteria:
* Relapse after autologous SCT
* Plasma cell leukemia
* Adverse cytogenetics, defined as 1 of the following:
* del(13q) = 11q translocation NOTE: \*Treatment failure is defined as relapse within 6 months OR failure to achieve remission
* Less than 10% blasts in bone marrow and no circulating blasts in peripheral blood for the following diagnoses:
* Primary or secondary leukemia
* Refractory anemia with excess blasts
* CML
* Other eligible diagnosis in transformation to acute leukemia
* Expected survival of approximately 1 year or less with conventional therapy
* No active CNS involvement by malignancy\*
* Prior CNS involvement with no current evidence of CNS malignancy allowed NOTE: \*Active CNS malignancy is defined by lymphoma: tumor mass on CT scan or leptomeningeal disease OR leukemia: blasts present on cerebrospinal fluid cytospin
* Availability of a donor who is a sibling, parent, or offspring who shares 1 full haplotype (HLA-A, -B, or -DR)
* Recipient and donor must have at least a 2-antigen disparity in either the host-versus-graft or graft-versus-host direction
* Parent or offspring donor who is mismatched for a single HLA antigen (i.e., 5/6 HLA) is allowed
* No sibling donor who is 6/6 HLA-matched OR mismatched for a single HLA antigen (i.e., 5/6 HLA)
* No unrelated donor identified in a prior or current National Marrow Donor Program registry search
PATIENT CHARACTERISTICS:
Age
* 18 to 55
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* At least 3 months
Hematopoietic
* See Disease Characteristics
* Absolute neutrophil count ≥ 1,000/mm\^3\*
* Platelet count ≥ 20,0000/mm\^3\* (without transfusion) NOTE: \*Lower values may be accepted at the discretion of the principal investigator or study chairperson if due to bone marrow involvement by malignancy
Hepatic
* ALT and AST ≤ 2.5 times upper limit of normal (ULN)\*
* Bilirubin ≤ 2.5 times ULN\*
* Unconjugated hyperbilirubinemia consistent with Gilbert's syndrome allowed
* No chronic active hepatitis B infection
* Hepatitis B core antibody positive allowed provided patient is surface antigen negative and has no evidence of active infection
* No hepatitis C viral infection
* Seronegative for anti-hepatitis C antibody and detectable hepatitis C viral RNA by reverse transcriptase-polymerase chain reaction assay NOTE: \*Higher levels may be accepted at the discretion of the principle investigator or study chairperson if such elevations are due to liver involvement by malignancy
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 50 mL/min
Cardiovascular
* LVEF ≥ 45%
Pulmonary
* DLCO ≥ 50% of expected value (corrected for blood hemoglobin level and alveolar volume)
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 year after study participation
* HIV negative
* No active infection not responding to antimicrobial therapy
* No psychiatric disorder that would preclude study compliance or informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* At least 2 weeks since prior monoclonal antibody therapy
Chemotherapy
* See Disease Characteristics
* At least 2 weeks since prior systemic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Recovered from all prior therapy
* No administration of tyrosine kinase (TK) inhibitors, including imatinib mesylate and dasatinib, during the conditioning regimen; TK inhibitor administration may resume 28 days after transplantationReferences
Publications (0)
Data not yet available