NCT00038844

Brief Summary

Objective of the low-dose transplant regimen must produce the following effects:

  1. 1.Suppression of the patient's immune system to prevent rejection of the donor cells;
  2. 2.Control of the lymphoma. The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable lymphoma

Timeline
Completed

Started Jun 2001

Longer than P75 for not_applicable lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 5, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2002

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 2, 2011

Status Verified

October 1, 2011

Enrollment Period

6.5 years

First QC Date

June 5, 2002

Last Update Submit

October 31, 2011

Conditions

LymphomaLeukemia

Keywords

LymphomaLeukemiaCampath-1 HCampathAlemtuzumabFludarabineFludarabine PhosphateFludaraCyclophosphamideCytoxanNeosarRituxanRituximab

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Surviving 100 days post-transplant

    30 Day Engraftment (Baseline) to 100 Days post-transplant

Study Arms (1)

Campath in Nonmyeloablative Transplantation

EXPERIMENTAL

Campath-1 H Starting Dose of 15 mg by vein daily, 3 days in a row + Fludarabine 30 mg/m2 by vein daily, 3 days in a row + Cyclophosphamide 1 gm/m2 by vein daily, 3 days in a row + Rituximab 375 mg/m2 by vein, given 8 days before transplant then weekly for 4 total doses.

Drug: Campath-1 H (Alemtuzumab)Drug: FludarabineDrug: CyclophosphamideDrug: Rituximab

Interventions

Campath-1 H (Alemtuzumab)DRUG

Starting Dose of 15 mg by vein daily, 3 days in a row.

Also known as: Campath, Alemtuzumab
Campath in Nonmyeloablative Transplantation
FludarabineDRUG

30 mg/m2 by vein daily, 3 days in a row.

Also known as: Fludarabine Phospate, Fludara
Campath in Nonmyeloablative Transplantation
CyclophosphamideDRUG

1 gm/m2 by vein daily, 3 days in a row.

Also known as: Cytoxan, Neosar
Campath in Nonmyeloablative Transplantation
RituximabDRUG

375 mg/m2 by vein, given (to some patients only, based on the subtypes of lymphomas) eight days before the transplant and then weekly for a total of 4 doses.

Also known as: Rituxan
Campath in Nonmyeloablative Transplantation

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Up to 70 years of age (physiological).
  • Any histological subtype of lymphoid malignancies (those with CD20 negative disease will not receive Rituximab).
  • Patients in relapse with a partial remission or stable disease.
  • Patients who failed a prior autologous transplant are also eligible.
  • Patients must have a matched unrelated donor and no human leukocyte antigen (HLA) identical sibling is available. Point scale (PS)\<2.
  • Patients are included even if they were previously exposed to Campath or Rituximab.

You may not qualify if:

  • Past history of anaphylaxis following exposure to rat- or mouse-derived COR-grafted humanized monoclonal antibodies.
  • Less than 4 weeks since prior chemotherapy counted from 1st day of treatment regimen.
  • Pregnancy or lactation.
  • HIV or HTLV-I positively.
  • Serum creatinine \>1.6mg/dl or serum bilirubin \>1.5mg/dl unless due to tumor.
  • Pulmonary function tests (PFTs) -OLCO\<50%, cardiac EF \<50% of predicted levels.
  • Patient with severe concomitant medical or psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaLeukemia

Interventions

Alemtuzumabfludarabinefludarabine phosphateCyclophosphamideRituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAntibodies, Monoclonal, Murine-Derived

Study Officials

  • Issa F. Khouri, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2002

First Posted

June 7, 2002

Study Start

June 1, 2001

Primary Completion

December 1, 2007

Study Completion

September 1, 2010

Last Updated

November 2, 2011

Record last verified: 2011-10

Locations

US(1)