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A Phase I/II Study Evaluating the Safety and Efficacy of AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies


Phase 1/Phase 2
18 Years
65 Years
Not Enrolling
Both
Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, Leukemia, Lymphoblastic, Acute, Lymphocytic Leukemia, Chronic, Myelodysplastic Syndromes, Multiple Myeloma, Lymphoma, Non-Hodgkin, Hodgkin Disease

Thank you

Trial Information

A Phase I/II Study Evaluating the Safety and Efficacy of AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies


This study will determine if peripheral blood cells collected following AMD3100 mobilization
can be used safely for hematopoietic cell transplantation into HLA-matched recipients.


Inclusion Criteria:



Donor criteria:

- Donor is 18 to 70 years of age inclusive

- If female and of child-bearing age, must be:

- non-pregnant,

- not breast feeding and

- using adequate contraception

- Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell for
transplant

- Donor must be willing to provide written informed consent.

- Adequate cardiac function with no history of congestive heart failure and no history
of atrial fibrillation or ventricular tachyarrhythmia.

- Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal
(Cockcroft-Gault equation)

- Adequate hepatic function as defined by a total bilirubin <2x normal or absence of
hepatic fibrosis/cirrhosis

- Adequate neurologic function as defined by:

- No evidence of a severe central or peripheral neurologic abnormality.

- No history of cerebrovascular accident or seizure disorder requiring
anticonvulsant medication

- Must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by
FDA licensed test.

- Must have an ECOG performance status of 0 or 1

- Must demonstrate ability to be compliant with study regimen.

- Must not have an active infection at the time of study entry

- Not have active alcohol or substance abuse within 6 months of study entry

- Not currently enrolled in another investigational agent study

- Not have any medical condition, which, in the opinion of the clinical investigator,
would interfere with his/her evaluation

Recipient criteria:

- 18 to 65 years of age inclusive

- Willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant

- Provide signed informed consent

- If female and of child-bearing age, must be:

- non-pregnant,

- not breast feeding, and

- using adequate contraception

Patient must have one of the following diagnoses:

- AML in 1st or subsequent remission or in relapse

- ALL in 1st or subsequent remission or in relapse

- MDS and intermediate 1 or 2, or high risk by the International Prognostic Scoring
System

- CML in accelerated or second chronic phase

- NHL or HD in 2nd or greater complete remission, partial remission,or refractory
relapse

- CLL Rai Stage 2-4, failing at least 2 prior regimens

- MM Stage 2-3

- Adequate cardiac function with a left ventricular ejection fraction ≥ 40%

- Adequate pulmonary function defined as:

- No severe or symptomatic restrictive or obstructive lung disease, and

- formal pulmonary function testing showing an forced expiratory volume at 1
second (FEV1) ≥50% of predicted and a diffusion capacity of the lung for carbon
monoxide (DLCO) ≥40% of predicted, corrected for hemoglobin

- Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal
(Cockcroft-Gault equation)

- Adequate hepatic function as defined by a total bilirubin <2x normal or absence of
hepatic fibrosis/cirrhosis

- Adequate neurologic function as defined by no evidence of a severe central or
peripheral neurologic abnormality. Patients with a history of previous central
nervous system tumor involvement are eligible provided they are without symptoms or
signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain

- No evidence of active infection at the time of the transplant preparative regimen or
at the time of transplantation

- Patient must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody
sero-negative, by FDA licensed test

- ECOG performance status of 0 or 1

- Must demonstrate ability to be compliant with medical regimen

- Not have active alcohol or substance abuse within 6 months of study entry

- Not be concurrently enrolled on another study involving an investigational agent

- Not have any medical condition, which, in the opinion of the clinical investigator,
would interfere with the evaluation of the patient

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of donors from whom a sufficient number of cells for transplantation are collected in no more than 2 LP procedures following mobilization with AMD3100

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

John F. DiPersio, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

03-0349

NCT ID:

NCT00241358

Start Date:

May 2004

Completion Date:

February 2010

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia, Myelogenous, Chronic
  • Leukemia, Lymphoblastic, Acute
  • Lymphocytic Leukemia, Chronic
  • Myelodysplastic Syndromes
  • Multiple Myeloma
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Plerixafor
  • Stem cell transplantation
  • Stem cells
  • Mobilization
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms
  • Chronic Disease

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110