Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Engraftment measured by donor-host chimerism in lymphoid and myeloid lines at days 15, 30, 45, 60, and 100

Safety Issue:

No

Principal Investigator

Ramaprasad Srinivasan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

Unspecified

Study ID:

CDR0000257524

NCT ID:

NCT00047060

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome

Name

Location

NIH - Warren Grant Magnuson Clinical CenterBethesda, Maryland  20892-1182