Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma

This study has been terminated.
(Slow Accrual.)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505921
First received: July 20, 2007
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

Primary Objectives:

  1. To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL).
  2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL.
  3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.
  4. To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL.

Condition Intervention Phase
Lymphoma
Drug: Campath-1H
Drug: G-CSF
Drug: GM-CSF
Drug: BCNU
Drug: Stem Cell Transplant
Drug: Preparative Regimen for Allogenic Stem Cell Transplantation
Drug: Cytarabine
Drug: Etoposide
Drug: Melphalan
Drug: Campath
Drug: Fludarabine
Drug: Cyclophosphamide
Radiation: Low dose total body irradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Participant Progression Free Survival at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.


Enrollment: 27
Study Start Date: March 2003
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Campath-1H

3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.

Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)

Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0.

Drug: Campath-1H
3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment.
Other Names:
  • Alemtuzumab
  • Campath
Drug: G-CSF
10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization.
Other Names:
  • Granulocyte colony-stimulating factor
  • G-CSF
  • GCSF
  • Filgrastim
  • Neupogen
Drug: GM-CSF
250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization.
Other Names:
  • GM-CSF
  • Granulocyte-Macrophage Colony Stimulating Factor
  • Sargramostim
  • Leukine
Drug: BCNU
300 mg/m2 IV over 1 hour on day -6
Other Names:
  • Carmustine
  • BiCNU
Drug: Stem Cell Transplant
Stem cell infusion on Day 0.
Other Name: SCT
Drug: Preparative Regimen for Allogenic Stem Cell Transplantation
Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy on day 0.
Drug: Cytarabine
200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses),
Other Names:
  • ARA
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrochloride
Drug: Etoposide
200 mg/m2 IV twice on day -5 to -2 (total 8 doses)
Other Names:
  • Etoposide phosphate
  • VePesid
Drug: Melphalan
140 mg/m2 IV on day -1.
Other Name: Alkeran
Drug: Campath
15 mg/day (days -6 to -4) for preparative regimen Allogenic Stem Cell Transplantation
Other Names:
  • Alemtuzumab
  • Campath-1H
Drug: Fludarabine
30 mg/m2 IV/day (days -6 to -4)
Other Names:
  • Fludarabine monophosphate
  • Fludara
Drug: Cyclophosphamide
750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4).
Other Names:
  • Cytoxan
  • Neosar
Radiation: Low dose total body irradiation
Low dose total body irradiation of 2 Gy day 0.
Other Name: LD-TBI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be less then 70 years old.
  • Patients must have chemosensitive disease, having undergone at least partial remission with less then 10% marrow involvement by gross pathologic examination if autologous transplantation is considered.
  • Newly diagnosed patients are eligible for autologous transplant. Patients in relapse would receive a non-myeloablative transplant if a sibling donor is available. Otherwise, patients would undergo autologous transplant if International Prognostic Index (IPI) is 0-1, or unrelated transplant if IPI is > 1.

Exclusion Criteria:

  • Criteria for exclusion are Human immunodeficiency virus (HIV) or Human T-lymphotropic virus (HTLV) seropositivity, pregnancy, cardiac ejection fraction by echo-cardiogram less than 40%, active central nervous system involvement, serum creatinine greater than 1.6 mg/dl or serum bilirubin greater than 1.5 mg/dl unless due to tumor, Absolute neutrophil count (ANC) less than 1,000/mm3 and platelets less than 100,000/mm3 unless due to tumor, performance status (ECOG scale) greater than 2, pulmonary function test- diffusing capacity of the Lung for Carbon Monoxide (DLCO) less than 40% of predicted, and severe concomitant medical or psychiatric illnesses.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505921

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bayer
Investigators
Principal Investigator: Issa F. Khouri, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505921     History of Changes
Other Study ID Numbers: ID02-645
Study First Received: July 20, 2007
Results First Received: September 30, 2011
Last Updated: November 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
T-Cell Lymphoma
Lymphoma
Campath-1H
Allogenic Transplantation
Stem Cell Transplant
Alemtuzumab

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Cytarabine
Fludarabine phosphate
Melphalan
Fludarabine
Etoposide phosphate
Alemtuzumab
Etoposide
Lenograstim
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
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on September 18, 2014