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

NCT00505921 | Terminated Phase 2 Results

• 1 other identifier: ID02-645
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

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

Conditions

Lymphoma

Keywords

T-Cell Lymphoma; Lymphoma; Campath-1H; Allogenic Transplantation; Stem Cell Transplant; Alemtuzumab

Outcome Measures

Primary Outcomes (1)

• Participant Progression Free Survival at 2 Years

  Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.

  2 years

Study Arms (1)

Campath-1H

EXPERIMENTAL

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; 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

Interventions

Campath-1H DRUG

3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment.

Also known as: Alemtuzumab, Campath

Campath-1H

G-CSF DRUG

10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization.

Also known as: Granulocyte colony-stimulating factor, GCSF, Filgrastim, Neupogen

Campath-1H

GM-CSF DRUG

250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization.

Also known as: Granulocyte-Macrophage Colony Stimulating Factor, Sargramostim, Leukine

Campath-1H

BCNU DRUG

300 mg/m2 IV over 1 hour on day -6

Also known as: Carmustine, BiCNU

Campath-1H

Stem Cell Transplant DRUG

Stem cell infusion on Day 0.

Also known as: SCT

Campath-1H

Preparative Regimen for Allogenic Stem Cell Transplantation DRUG

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.

Campath-1H

Cytarabine DRUG

200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses),

Also known as: ARA, Ara-C, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride

Campath-1H

Etoposide DRUG

200 mg/m2 IV twice on day -5 to -2 (total 8 doses)

Also known as: Etoposide phosphate, VePesid

Campath-1H

Melphalan DRUG

140 mg/m2 IV on day -1.

Also known as: Alkeran

Campath-1H

Campath DRUG

15 mg/day (days -6 to -4) for preparative regimen Allogenic Stem Cell Transplantation

Also known as: Alemtuzumab, Campath-1H

Campath-1H

Fludarabine DRUG

30 mg/m2 IV/day (days -6 to -4)

Also known as: Fludarabine monophosphate, Fludara

Campath-1H

Cyclophosphamide DRUG

750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4).

Also known as: Cytoxan, Neosar

Campath-1H

Low dose total body irradiation RADIATION

Low dose total body irradiation of 2 Gy day 0.

Also known as: LD-TBI

Campath-1H

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bayer: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma; Lymphoma, T-Cell

Interventions

Alemtuzumab; Granulocyte Colony-Stimulating Factor; Filgrastim; Granulocyte-Macrophage Colony-Stimulating Factor; Colony-Stimulating Factors; sargramostim; Carmustine; Stem Cell Transplantation; Cytarabine; Etoposide; etoposide phosphate; Melphalan; fludarabine; fludarabine phosphate; Cyclophosphamide; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Radiotherapy; Investigative Techniques

Limitations and Caveats

Early termination due to slow accrual.

Results Point of Contact

• Title: Issa F. Khouri, MD / Associate Professor
• Organization: UT MD Anderson Cancer Center

pmcadams@mdanderson.org

713-792-8848

Study Officials

• Issa F. Khouri, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 25, 2007
• Study Start: March 1, 2003
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 16, 2011
• Results First Posted: November 7, 2011

Record last verified: 2011-11

Locations

US (1)