Phase 2
N=52
Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
Hodgkin's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00385788 ↗Enrolled (actual)
52
Serious AEs
15.4%
Results posted
May 2018
Primary outcome: Primary: Transplant Related Mortality Rate — 1; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Fludarabine (Drug); Melphalan (Drug); Antithymocyte Globulin (Drug); Allogeneic Stem Cell Infusion (Procedure); Tacrolimus (Drug); Filgrastim (G-CSF) (Drug); Methotrexate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transplant Related Mortality Rate |
1; 6 | — |
Summary
The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.
Eligibility Criteria
Inclusion Criteria
- Patients /= 40%, forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and corrected diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% predicted.
- Patients must have an HLA-compatible related or unrelated donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells. In the event of transplants from matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 ("8 of 8 match") is required.
- Women of childbearing potential must have a negative serum pregnancy test within two weeks of study entry and should be advised to avoid becoming pregnant. Men should be advised to not father a child while on treatment. Both women of childbearing potential and men must agree to practice effective methods of contraception.
- Patients must be capable and willing to sign informed consent.
Exclusion Criteria
- Patients with documented disease progression on salvage chemotherapy.
- Nursing or pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately.
- Severe concomitant medical or psychiatric illness.
- Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.
- Chronic active hepatitis or cirrhosis.
- Active or uncontrolled infection.
- Radiation therapy involving chest (axilla excluded), mediastinum, or abdomen (i.e., small or large bowel) completed within 10 weeks of transplant admission. Radiation therapy shortly before the start of the preparative regimen is allowed.
- Prior or concurrent malignancies (including myelodysplasia) except resected basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent 5 years previously will be allowed.
Data sourced from ClinicalTrials.gov (NCT00385788). 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.