Clinical trial · Interventional
Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer
Non-Myeloablative Allogeneic Hematopoietic Cell 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 low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with 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 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloproliferative Neoplasms | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Plasma Cell Neoplasm | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic cell transplantation | Procedure | — | UNRESOLVED |
| allopurinol | Drug | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| G-CSF | Biological | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| tacrolimus | Drug |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Non myeloblative allogeneic transplant
- description
- Non myeloblative allogeneic hematopoietic cell transplantation after prior autologous transplantation
- interventionNames
- Biological: anti-thymocyte globulin
- Biological: G-CSF
- Drug: busulfan
- Drug: fludarabine phosphate
- Drug: methotrexate
- Drug: mycophenolate mofetil
- Drug: tacrolimus
- Procedure: allogeneic cell transplantation
- Drug: allopurinol
Primary outcomes (1)
- measure
- Treatment-related mortality
- timeFrame
- 6 months post transplant
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 69 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed hematologic malignancy, including one of the following:
* Chronic lymphocytic leukemia (CLL)
* Absolute lymphocytosis greater than 5,000/mm\^3
* Lymphocytes must appear morphologically mature with less than 55% prolymphocytes
* Lymphocyte phenotype with expression of CD19 and CD5
* Prolymphocytic leukemia (PLL)
* Morphologically confirmed
* Absolute lymphocytosis greater than 5,000/mm\^3
* More than 55% prolymphocytes
* Non-Hodgkin's lymphoma or Hodgkin's lymphoma
* Any WHO histologic subtype allowed except mantle cell lymphoma
* Core biopsies allowed if they contain adequate tissue for primary diagnosis and immunophenotyping
* No bone marrow biopsy as the sole diagnostic means for follicular lymphoma
* Multiple myeloma
* Active disease requiring treatment
* Durie-Salmon stage I, II, or III
* Acute myeloid leukemia
* Documented control (i.e., less than 10% bone marrow blasts and no circulating blasts)
* Myelodysplastic syndromes
* Documented disease by WHO criteria
* Must have evidence of relapse/progression at least 6 months after prior high-dose chemotherapy with autologous hematopoietic stem cell support
* Absence of CD23 expression for CLL or PLL allowed provided there is no morphologic evidence of mantle cell lymphoma
* Availability of any of the following donor types:
* HLA-identical sibling (6/6)
* 9/10 matched related donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci
* Only a single mismatch at one class I or II allele allowed
* 10/10 matched unrelated donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci
* No syngeneic donors
PATIENT CHARACTERISTICS:
Age
* Under 70
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin no greater than 3 times upper limit of normal (ULN)
* AST no greater than 3 times ULN
Renal
* Creatinine clearance at least 40 mL/min
Cardiovascular
* LVEF at least 30% by MUGA
Pulmonary
* DLCO greater than 40%
* No symptomatic pulmonary disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No uncontrolled diabetes mellitus
* No active serious infection
* No known hypersensitivity to E. coli-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* More than 4 weeks since prior surgeryReferences
Publications (2)
- RESULTBashey A, Owzar K, Johnson JL, Edwards PS, Kelly M, Baxter-Lowe LA, Devine S, Farag S, Hurd D, Ball E, McCarthy P, Lister J, Shea TC, Linker C. Reduced-intensity conditioning allogeneic hematopoietic cell transplantation for patients with hematologic malignancies who relapse following autologous transplantation: a multi-institutional prospective study from the Cancer and Leukemia Group B (CALGB trial 100002). Biol Blood Marrow Transplant. 2011 Apr;17(4):558-65. doi: 10.1016/j.bbmt.2010.07.015. Epub 2010 Jul 30. PMID 20674758
- RESULTBashey A, Owzar K, Johnson JL, et al.: Reduced-intensity allogeneic transplantation after failure of autologous transplantation: a prospective multi-center CALGB study. [Abstract] Blood 108 (11): A-3122, 2006.