Clinical trial · Interventional

Fludarabine Phosphate, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed Hodgkin Lymphoma

A Phase II Study of Reduced Intensity Sibling Allogeneic Transplantation for Relapsed, Chemosensitive, PET-positive Hodgkin Lymphoma

NCT00907036CI-TRIAL-00011581unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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 cyclosporine before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called 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 the side effects of fludarabine phosphate, melphalan, and alemtuzumab followed by donor stem cell transplant in treating patients with relapsed Hodgkin lymphoma.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
alemtuzumab	Biological	Alemtuzumab	ALIAS
allogeneic hematopoietic stem cell transplantation	Procedure	—	UNRESOLVED
cyclosporine	Drug	—	UNRESOLVED
donor lymphocytes	Biological	—	UNRESOLVED
fludarabine phosphate	Drug	Fludarabine	ALIAS
melphalan	Drug	Melphalan	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
3-year progression-free survival

Secondary outcomes (8)

measure
Donor engraftment rates, including chimerism at 3 and 6 months
measure
Non-relapse mortality at 100 days and at 1 and 2 years post-transplant
measure
Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0
measure
Incidence, severity, and timing of graft-vs-host disease
measure
Response rates
measure
Relapse rates

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years
Maximum age: 65 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Confirmed diagnosis of Hodgkin lymphoma, meeting all of the following criteria:

  * Achieved partial or complete remission (using standard criteria) after salvage chemotherapy
  * Relapsed after first remission with residual fludeoxyglucose F 18-avid lesions
* Available HLA-matched sibling donor

PATIENT CHARACTERISTICS:

* WHO performance status 0-1
* Creatinine clearance ≥ 50 mL/min (measured by EDTA clearance or 24-hour urine collection)
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2 times ULN
* LVEF ≥ 40%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months (or 3 months for women) after completion of study therapy
* No other malignancy within the past 5 years except for nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma
* No HIV positivity
* No symptomatic respiratory compromise
* No concurrent serious medical condition that would preclude transplantation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior high-dose therapy or allograft

References

Publications (0)

Data not yet available

No reference posted for this study.