N/A
N=66
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
Chronic Myeloproliferative Disorders · Leukemia · Lymphoma · Multiple Myeloma and Plasma Cell Neoplasm · Myelodysplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00453206 ↗Enrolled (actual)
66
Serious AEs
9.2%
Results posted
Jul 2014
Primary outcome: Primary: Treatment-related Mortality Within the First 6 Months After Transplantation — 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- allogeneic bone marrow transplantation (Procedure); allogeneic hematopoietic stem cell transplantation (Procedure); nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure); peripheral blood stem cell transplantation (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-related Mortality Within the First 6 Months After Transplantation |
6 | — |
| SECONDARY Complete Response |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Disease-free Survival |
— | — |
| SECONDARY Graft-versus-host Disease |
— | — |
| SECONDARY Iron Status at the Time of Transplantation |
— | — |
| SECONDARY Quality of Life at the Time of Transplantation |
— | — |
| SECONDARY Treatment-related Mortality at 100 Days After Transplantation |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed hematological disease, including any of the following:
- Chronic lymphocytic leukemia
- Absolute lymphocytosis > 5,000/µL
- Morphologically mature lymphocytes with 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., 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 nursing
Data sourced from ClinicalTrials.gov (NCT00453206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.