NCT00048412

Brief Summary

  1. 1.To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy.
  2. 2.To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.
  3. 3.To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

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, 2000

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2004

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

4.5 years

First QC Date

October 30, 2002

Last Update Submit

January 15, 2020

Conditions

Myelodysplastic DisordersLeukemiaMultiple MyelomaPlasma Cell DyscrasiaLymphoproliferative Disorders

Interventions

FLUDARABINEDRUG
CAMPATH 1HDRUG
FK50DRUG
Stem Cell Collection and InfusionPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma.
  • Conditions that increase treatment related mortality (need one or more to be eligible):
  • Greater to or equal to 50 years of age.
  • EF of less than 45%
  • DLCO less than 50% of FEV1 50-75% of predicted value.
  • Diabetes Mellitus
  • Renal Insufficiency (but creatine clearance not less than 25ml/min).
  • Prior recent history of systemic fungal infection.
  • rd or greater remission of AML or ALL
  • More than 1 year of diagnosis (CML or Myeloma patients)
  • Multiple types of treatment regimens. (equal to or more than 3)
  • Prior autologous or allogeneic stem cell transplantation.
  • Significant grade III or IV neurologic or hepatic toxicity from previous treatment.
  • No matched sibling donor.
  • Available healthy donor without any contraindications for donation. 5/6 or 6/6 related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1)
  • +3 more criteria

You may not qualify if:

  • Patient is pregnant, lactating or unwilling to use contraceptives
  • HIV positive patient
  • Uncontrolled intercurrent infection
  • Refractory AML, or ALL
  • Untreated Blast Crisis for CML
  • Uncontrolled High-grade lymphoproliferative disease/lymphoma.
  • Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)
  • Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)
  • Hemodialysis dependent
  • Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal.
  • Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)
  • Active CNS disease from hematological disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

LeukemiaMultiple MyelomaParaproteinemiasLymphoproliferative Disorders

Interventions

fludarabineAlemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesBlood Protein DisordersHemorrhagic DisordersImmunoproliferative DisordersImmune System DiseasesLymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • George Carrum, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 30, 2002

First Posted

November 1, 2002

Study Start

June 1, 2000

Primary Completion

November 12, 2004

Study Completion

November 12, 2004

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(2)