Alemtuzumab Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Mycosis Fungoides/Sezary Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00047060
First received: October 3, 2002
Last updated: June 23, 2009
Last verified: June 2009
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Purpose
RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Allogeneic peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the anticancer therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and cyclosporine may prevent this rejection.
PURPOSE: This phase I/II trial is studying how well giving alemtuzumab together with chemotherapy and donor peripheral stem cell transplantation works in treating patients with advanced mycosis fungoides and/or Sezary syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: alemtuzumab Drug: cyclophosphamide Drug: fludarabine phosphate |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study Of HLA-Matched Mobilized Peripheral Blood Hematopoetic Stem Cell Transplantation For Advanced Mycosis Fungoides/Sezary Using NonMyeloablative Conditioning With Campath-1H |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Engraftment measured by donor-host chimerism in lymphoid and myeloid lines at days 15, 30, 45, 60, and 100 [ Designated as safety issue: No ]
- Response (complete [CR] and partial responses [PR] and stable [SD] or progressive disease [PD]) at days 30, 60, and 100 [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immune reconstitution measured by lymphocyte subset analysis and T cell repertoire at days 15, 30, 45, 60, and 100 [ Designated as safety issue: No ]
- Safety measured by incidence and severity of post-transplant complications [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 58 |
| Study Start Date: | July 2002 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Regimen A
Patients receive alemtuzumab IV over 2 hours on days -28, -27, -26, -24, -22, -19, -17, and -15 and fludarabine IV over 30 minutes on days -5 to -1.
|
Biological: alemtuzumab
Given IV
Drug: fludarabine phosphate
Given IV
|
|
Experimental: Regimen B
Patients receive alemtuzumab IV over 2 hours on days -28, -27, -26, -24, -22, -19, -17, and -15; fludarabine IV over 30 minutes on days -5 to -1; and cyclophosphamide IV over 1 hour on days -7 and -6.
|
Biological: alemtuzumab
Given IV
Drug: cyclophosphamide
Given IV
Drug: fludarabine phosphate
Given IV
|
Detailed Description:
OBJECTIVES:
- Evaluate the ability of a conditioning regimen comprising alemtuzumab and fludarabine with or without cyclophosphamide to produce at least 80% sustained engraftment in patients with advanced mycosis fungoides/Sezary syndrome.
- Evaluate allogeneic graft-versus-tumor effects in mycosis fungoides/Sezary syndrome patients treated with a nonmyeloablative conditioning regimen followed by HLA-matched allogeneic peripheral blood stem cell transplantation.
- Determine the safety and toxicity of this regimen in these patients.
- Determine tumor response, disease-free survival, and overall survival of patients treated with this regimen.
- Determine the rate and extent of lymphocyte subset reconstitution in patients treated with this regimen.
- Determine transplant-related morbidity, including rates of acute and chronic graft-versus-host disease and infectious complications, and mortality in patients treated with this regimen.
OUTLINE: Patients receive 1 of 2 nonmyeloablative conditioning regimens, depending on engraftment efficacy in prior patients.
- Regimen A: Patients receive alemtuzumab IV over 2 hours on days -28, -27, -26, -24, -22, -19, -17, and -15 and fludarabine IV over 30 minutes on days -5 to -1.
- Regimen B: Patients receive alemtuzumab and fludarabine as in regimen A plus cyclophosphamide IV over 1 hour on days -7 and -6.
Patients also receive graft-versus-host disease prophylaxis comprising oral cyclosporine twice a day beginning on day -4 and continuing until day 100.
Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
Donor T cell and myeloid chimerism will be evaluated and will guide decisions regarding donor lymphocyte infusions.
Patients are followed every 2 months for 6 months, every 3 months for 1.5 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 9-58 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed mycosis fungoides (MF)
- Stage IIB, III, IVA, or IVB
- Progressive disease after at least 1 treatment regimen
- Sezary syndrome (SS)
- Clinically or radiographically evaluable disease
- Anticipated median survival of less than 5 years or debilitation as result of disease
- Less than 25% of liver involved with metastatic tumor by CT scan
- No CNS metastases by MRI
- 6/6 HLA-matched family donor available
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Performance status
- ECOG 0-1
Life expectancy
- See Disease Characteristics
- At least 3 months
Hematopoietic
- Not specified
Hepatic
- See Disease Characteristics
- Bilirubin no greater than 4 mg/dL
- Transaminases no greater than 5 times upper limit of normal
Renal
- Creatinine no greater than 2 mg/dL
Cardiovascular
- LVEF at least 40%
Pulmonary
- DLCO at least 60% of predicted
Other
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- No major organ dysfunction or failure or major anticipated illness that would preclude transplantation
- No psychiatric disorder or mental deficiency that would preclude study
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 30 days since prior therapy for MF or SS
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047060
Locations
| United States, Maryland | |
| NIH - Warren Grant Magnuson Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Patient Recruitment 800-411-1222 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Ramaprasad Srinivasan, MD | National Heart, Lung, and Blood Institute (NHLBI) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ramaprasad Srinivasan, National Heart, Lung, and Blood Institute |
| ClinicalTrials.gov Identifier: | NCT00047060 History of Changes |
| Obsolete Identifiers: | NCT00042640 |
| Other Study ID Numbers: | CDR0000257524, NHLBI-02-H-0250 |
| Study First Received: | October 3, 2002 |
| Last Updated: | June 23, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome |
Additional relevant MeSH terms:
|
Lymphoma Mycoses Mycosis Fungoides Sezary Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell Lymphoma, Non-Hodgkin Cyclophosphamide Fludarabine monophosphate |
Campath 1G Fludarabine Alemtuzumab Vidarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 19, 2013