Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	70 and under	NCI	MSKCC-01092 NCI-G01-2028, NCT00027560

Objectives

1. Evaluate the proportion of patients with lymphohematopoietic malignancies who achieve durable hematopoietic reconstitution after receiving a nonmyeloablative regimen comprising melphalan, fludarabine, and alemtuzumab followed by allogeneic hematopoietic stem cell transplantation.
2. Determine the incidence and characteristics of peritransplantation morbidity and mortality (e.g., hepatic veno-occlusive disease or infections) in patients treated with this regimen.
3. Determine the incidence and severity of acute and chronic graft-versus-host disease in these patients treated with this regimen.
4. Determine the overall and disease-free survival at 1, 3, 6, 12, and 24 months after transplantation in these patients.
5. Determine the quality of bone marrow and peripheral blood chimerism at 1, 3, 6, 12, and 24 months after transplantation in these patients.
6. Assess the kinetics of immune reconstitution in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Diagnosis of one of the following:
  • Relapsed or primary refractory non-Hodgkin's lymphoma (NHL)
    • Aggressive NHL histologies allowed if the following criteria are met:
      • Chemosensitive/radiosensitive, nonprogressive, or stable on therapy
      • Ineligible for autologous hematopoietic stem cell transplantation because of disease in bone marrow
  
  
  
  • Chemosensitive relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia
  
  
  
  • Relapsed or primary refractory Hodgkin's lymphoma
  
  
  
  • Stage II or III multiple myeloma
  
  
  
  • Advanced or refractory Waldenstrom's macroglobulinemia
  
  
  



• Ineligible for protocols involving myeloablative conditioning regimens by virtue of any of the following conditions:
  • Advanced age
  • Intensity of prior radiotherapy and/or chemotherapy
  • History of prior toxicity associated with chemotherapy/radiotherapy
  • Existing organ damage



• Diagnosis of chronic myeloid leukemia, high-risk acute myelogenous leukemia, or myelodysplastic syndromes allowed if no alternative, active, higher priority allogeneic transplantation protocol exists



• Availability of an HLA-matched or a single HLA allele disparate related or unrelated donor (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06)



• No uncontrolled CNS disease

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

Other:

• Concurrent cardiac medication for congestive heart failure allowed

Patient Characteristics:

Age:

• 70 and under

Performance status:

• Karnofsky 40-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.5 mg/dL
• AST and ALT no greater than 3 times normal unless due to liver involvement with disease

Renal:

• Creatinine no greater than 2.0 mg/dL

  OR

• Creatinine clearance at least 30 mL/min

Cardiovascular:

• Resting LVEF at least 30% by echocardiogram or MUGA scan

Pulmonary:

• DLCO at least 40% of predicted
• No requirement for supplementary oxygen

Other:

• HIV negative
• HTLV negative
• No active or uncontrolled bacterial, viral, or fungal infection that would preclude myelosuppressive chemotherapy
• Not pregnant or nursing
• Negative pregnancy test

Expected Enrollment

A maximum of 50 patients (25 HLA-matched related and 25 HLA-mismatched related or matched unrelated) will be accrued for this study within 2 years (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06).

Outcomes

Durable hematopoietic reconstitution
Incidence and characteristics of peritransplantation morbidity and mortality
Incidence and severity of acute and chronic graft-versus-host disease
Overall and disease-free survival at 1, 3, 6, 12, and 24 months after transplantation

Quality of bone marrow and peripheral blood chimerism at 1, 3, 6, 12, and 24 months after transplantation
Kinetics of immune reconstitution

Outline

Patients are stratified according to donor type (HLA-matched related vs HLA-matched unrelated, single HLA-allele disparate related, or unmatched) (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06).

Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days -8 to -5, fludarabine IV over 30 minutes on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Allogeneic peripheral blood stem cells or bone marrow is infused on day 0.

Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12 hours beginning on day -1 and continuing orally as tolerated until day 100.

Patients are followed every 6 weeks for 6 months, every 3 months for 6 months, every 3-6 months for 1 year, and then annually thereafter or as clinically indicated.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Hugo R. Castro-Malaspina, MD, Protocol chair		Ph: 212-639-8197; 800-525-2225

Registry Information
Official Title		Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphohematopoietic Malignancies
Trial Start Date		2001-07-31
Registered in ClinicalTrials.gov		NCT00027560
Date Submitted to PDQ		2001-10-01
Information Last Verified		2006-08-15
NCI Grant/Contract Number		CA08748

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