Clinical trial · Interventional
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
Reduced Intensity Allogeneic Hematopoietic Cell Transplantation for Patients With Hematological Diseases
- 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 fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, mycophenolate mofetil, and antithymocyte globulin before and after transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer or abnormal cells as not belonging in the patient's body and destroy them (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 hematologic cancer or other diseases.
Conditions
Conditions (5)
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 Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Treatment-related Mortality Within the First 6 Months After Transplantation
- timeFrame
- 6 months
Secondary outcomes (7)
- measure
- Complete Response
- timeFrame
- monthly
- measure
- Overall Survival
- timeFrame
- monthly
- measure
- Disease-free Survival
- timeFrame
- monthly
- measure
- Graft-versus-host Disease
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed hematological disease, including any of the following:
* Chronic lymphocytic leukemia
* Absolute lymphocytosis \> 5,000/µL
* Morphologically mature lymphocytes with \< 55% prolymphocytes
* Lymphocyte phenotype with expression of CD19 and CD5
* Absence of CD23 expression allowed provided disease is morphologically distinguished from mantle cell lymphoma
* Prolymphocytic leukemia
* Absolute lymphocytosis \> 5,000/µL
* Morphologically mature lymphocytes with \> 55% prolymphocytes
* Non-Hodgkin's or Hodgkin's lymphoma
* Any WHO classification histologic subtype
* Diagnosis by core biopsy allowed provided there is adequate tissue for diagnosis and immunophenotyping
* Diagnosis by bone marrow biopsy not acceptable for follicular lymphomas
* Multiple myeloma
* Has received ≥ 1 prior treatment regimen
* Has a partial response or greater by the Blade Criteria
* Patients who achieved complete remission are eligible
* Acute myeloid leukemia
* Documented control (i.e., \< 10% bone marrow blasts and no circulating blasts)
* Myelodysplastic syndromes
* Documented disease as defined by WHO or French-American-British Cooperative group criteria
* Chronic myelogenous leukemia
* Patients with atypical chronic myelogenous leukemia (i.e., absent Philadelphia chromosome) are eligible
* Polycythemia vera
* Documented disease as defined by WHO criteria (i.e., A1 + A2, and any other category A, OR A1 + A2, and any 2 category B):
* A1: Total red blood cell mass \> 25% above mean normal predicted value OR hemoglobin \> 18.5 g/dL in males, 16.5 g/dL in females (hematocrit ≥ 60% in males or ≥ 56% in females)
* A2: No cause of secondary erythrocytosis (absence of familial erythrocytosis, no elevation of epoetin alfa \[EPO\] due to hypoxia, high oxygen affinity hemoglobin, truncated EPO receptor, or inappropriate ectopic EPO production)
* A3: Splenomegaly
* A4: Clonal genetic abnormality other than the Philadelphia chromosome
* A5: Endogenous erythroid colony formation in vitro
* B: Platelet count \> 400,000/mm³, WBC \> 12,000/mm³, bone marrow biopsy with prominent erythroid and megakaryocytic proliferation, and low serum EPO
* Chronic idiopathic myelofibrosis
* Documented disease as defined by WHO criteria
* Must have a HLA-identical donor, a matched unrelated donor, or a HLA 9/10 related donor meeting the following criteria:
* HLA-identical sibling (6/6)
* Serologic typing for class I (A, B)
* Molecular typing for class II (DRB1)
* 9/10 matched related donor
* High-resolution molecular typing at HLA-A, B, C, DRB1, and DQB1
* Only a single mismatch at one class I or II allele allowed
* 10/10 matched unrelated donor
* Molecular identity at HLA-A, B, C, DRB1, and DQB1 by high-resolution typing
* Syngeneic donors are not eligible
* Creatinine clearance ≥ 40 mL/min
* Bilirubin ≤ 3 times upper limit of normal (ULN)
* AST ≤ 3 times ULN
* DLCO ≥ 40% with no symptomatic pulmonary disease
* LVEF ≥ 30% by cardiac MRI or echocardiogram with no symptomatic cardiac disease
* Fertile patients willing to use effective contraception
Exclusion Criteria:
* Uncontrolled diabetes mellitus
* Active serious infection
* Known hypersensitivity to E. coli-derived products
* Known HIV positivity
* History of another malignancy\*, meeting the following criteria:
* Non-skin malignancy or melanoma within the past 5 years
* Concomitant malignancy that has not been curatively treated
* NOTE: \*However, cancer survivors who have undergone potentially curative therapy for a prior malignancy at least 5 years before enrollment and are deemed at low risk of \< 30% for recurrence by their treating physicians is considered
* Pregnant or nursingReferences
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