Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
Reduced Intensity Allogeneic Hematopoietic Cell Transplantation for Patients With Hematological Diseases
2 other identifiers
interventional
66
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedResults Posted
Study results publicly available
July 2, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedSeptember 10, 2018
August 1, 2018
7 years
March 27, 2007
May 28, 2014
August 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-related Mortality Within the First 6 Months After Transplantation
6 months
Secondary Outcomes (7)
Complete Response
monthly
Overall Survival
monthly
Disease-free Survival
monthly
Graft-versus-host Disease
monthly
Iron Status at the Time of Transplantation
baseline
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +34 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
By the time the primary objective of this trial was completed, the treatment approach of the trial had become standard of care. Analysis was therefore limited.
Results Point of Contact
- Title
- David Hurd, MD
- Organization
- Wake Forest University Health Sciences
Study Officials
- STUDY CHAIR
David Hurd, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2007
First Posted
March 28, 2007
Study Start
February 1, 2007
Primary Completion
February 1, 2014
Study Completion
August 1, 2014
Last Updated
September 10, 2018
Results First Posted
July 2, 2014
Record last verified: 2018-08