Clinical trial · Interventional
Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant
Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation as Second Transplantation for Patients With Disease Relapse or Myelodysplasia After Prior Autologous Transplantation
- 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: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| 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 (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| donor lymphocytes | Biological | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60. Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover. Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks. Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years.
- interventionNames
- Biological: anti-thymocyte globulin
- Biological: donor lymphocytes
- Biological: filgrastim
- Biological: therapeutic allogeneic lymphocytes
- Drug: busulfan
- Drug: fludarabine phosphate
- Drug: methotrexate
- Drug: mycophenolate mofetil
- Drug: tacrolimus
- Other: reduced-intensity transplant conditioning procedure
- Procedure: allogeneic hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 69 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed hematologic malignancies:
* Chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL)
* Absolute lymphocytosis of \> 5,000/μL
* Lymphocytes must appear morphologically mature with \< 55% prolymphocytes (CLL)
* Patients with \> 55% prolymphocytes are considered as having PLL
* Lymphocyte phenotype with expression of CD20, CD19, and CD5 (CLL)
* Non-Hodgkin lymphoma
* Any WHO classification of histologic subtype
* Core biopsies acceptable for primary diagnosis and immunophenotyping
* Bone marrow biopsies as sole means of diagnosis not allowed for follicular lymphoma
* Hodgkin lymphoma
* Any WHO classification of histologic subtype
* Core biopsies acceptable for primary diagnosis and immunophenotyping
* Bone marrow biopsy is required
* Multiple myeloma
* Patients must have active disease requiring treatment (Durie-Salmon stage I-III)
* Acute myeloid leukemia
* Must have \< 10% bone marrow blasts and no circulating blasts
* Myelodysplastic syndrome (MDS)
* MDS as define by WHO criteria
* Must have \< 10% marrow blasts
* Relapsed or progressive disease or myelodysplasia ≥ 6 months after prior high-dose chemotherapy with autologous hematopoietic cell support
* Prior syngeneic transplantation allowed
* Healthy donor meeting one of the following criteria:
* HLA-identical sibling (6/6)
* Serologic typing for class I (A, B) and molecular typing for class II (DRB1) required
* 8/8 matched-unrelated donor
* Molecular identity at HLA A, B, C, and DRB1 by high-resolution typing required
* No syngeneic donors
PATIENT CHARACTERISTICS:
* Creatinine clearance ≥ 40 mL/min
* Total bilirubin ≤ 2 mg/dL
* AST ≤ 3 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* DLCO ≥ 40% with no symptomatic pulmonary disease
* LVEF ≥ 30% by MUGA or ECHO
* No uncontrolled diabetes mellitus or active serious infection
* No known hypersensitivity to E.coli-derived products
* No HIV infection
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks should elapse between prior standard cytotoxic chemotherapy, radiation therapy, or surgery and the planned start of the preparative regimen on day -7References
Publications (0)
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