Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases
1 other identifier
interventional
29
1 country
1
Brief Summary
Donor: This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies. The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease \[GvHD\] (grade III-IV). Secondary objectives include assessments of recipient having donor derived platelet engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival, clinical safety and device performance of the CliniMACS CD34 selection device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 leukemia
Started Sep 2001
Typical duration for phase_2 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 5, 2002
CompletedFirst Posted
Study publicly available on registry
June 7, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
August 7, 2012
CompletedAugust 10, 2012
August 1, 2012
7.8 years
June 5, 2002
June 21, 2012
August 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Absolute Neutrophil Count Engraftment
Absolute neutrophil engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 \* 10\^9/L. Baseline to Day 30 post transplant.
Day 0 up to Day 30
Study Arms (1)
CD34 PBPC
EXPERIMENTALCD34 peripheral blood progenitor cell (PBPC) transplants in 3 groups: 1) HLA-matched Sibling Transplant Patients; 2) Unrelated Donor Transplant Patients; 3) Haplo Identical Transplant Patients. Preparative regimen is 140 mg/m\^2 Melphalan on day -8, 10 mg/kg Thiotepa on day -7, 160 mg/m\^2 Fludarabine over 4 days on days -6, -5, -4, -3 and 1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.
Interventions
Haploidentical peripheral blood progenitor cell (PBPC) transplants on Day 0.
160 mg/m\^2 over 4 days on days -6, -5, -4, -3
1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.
Eligibility Criteria
You may qualify if:
- Male or female recipients must have histopathologically confirmed diagnosis of hematological or lymphatic malignancy in one of the following categories:
- Acute Leukemia: Recipients must have acute leukemia in second or greater remission in relapse, or primary refractory disease. Acute leukemia (in first remission with poor risk factors and molecular prognosis; acute myelogenous leukemia (AML) with -5, -7, t(6:9), +8, -11q23 and Acute lymphoblastic leukemia (ALL) with Phil+ t(9:22), t(4:11) and secondary remission inclusive).
- Chronic myelogenous leukemia: Chronic Myeloid Leukemia (CML) in accelerated phase, blast crisis or second chronic phase.
- Myelodysplastic syndrome (in high and intermediate risk categories) - marrow blast \> 10% on differential.
- Non-Hodgkin's lymphoma in relapse
- Refractory chronic lymphoid leukemia (CLL) - refractory to fludarabine based regimen, unrelated donor and haploidentical only
- The recipient must be \<=60 years old at time of registration.
- The recipient must have a related donor haploidentical for human leukocyte antigen (HLA), A, B, C, or DR loci. They may be partial matched on the other haplotype.
- Recovery from prior therapy, chemotherapy, or radiotherapy, as defined by: Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2; have recovered from the toxicity of prior major chemotherapy at the start of the preparative regimen on this protocol
- Adequate cardiac and pulmonary function (Left ventricular ejection fraction (LVEF) \>45%, Carbon Monoxide Diffusing Capacity (DL CO)\>50% corrected for hemoglobin)
- Serum creatinine \<1.5 mg/dL or creatinine clearance \>50 ml/min for those above serum creatinine of 1.5; serum bilirubin \<2.0 mg/dL; Aspartate transaminase (AST)/alanine aminotransferase (ALT) \<2\* Upper limits of normal (ULN) (unless secondary to disease)
- Females of childbearing potential must have a negative serum or urine beta-HCG test within three weeks of registration. Patients will be informed of the risk of not receiving adequate contraception.
- No prior cancer within five years with the exception of surgically cured non-melanoma skin cancer or in situ cancer of the cervix
- The recipient and/or the recipient's legal guardian must have been informed of the investigational nature of this study and have signed a consent form which is in accordance with Federal guidelines and the guidelines of the participating institution.
- Donor age must be 4-80 years and weight greater than 20 kg.
- +8 more criteria
You may not qualify if:
- Participation in other clinical trials which involve investigational drugs or devices that might influence the endpoints of this study
- Evidence of active hepatitis (B and/or C) or cirrhosis
- Neither the recipient nor the donor may be HIV positive
- Presence of any other active, uncontrolled bacterial, viral or fungal infection.
- Uncontrolled central nervous system (CNS) involvement with tumor cells
- Documented allergy to murine proteins or iron dextran
- The recipient is a lactating female or, if of child-bearing potential, is unwilling to implement adequate birth control.
- Severe end-organ dysfunctions, particularly neurologic deficits detectable by clinical examination or significant intellectual impairment in metabolic disorders
- Evidence of active infection (including urinary tract infection, or upper respiratory tract infection) or hepatitis (on screening).
- Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis.
- Factors that place the donor at increased risk for complications from leukapheresis or G-CSF therapy such as pulmonary hypertension, coronary artery disease, peripheral vascular disease, cerebral vascular disease.
- Lactating female or, if of child-bearing potential, is unwilling to implement adequate birth control.
- Donors who are hepatitis positive, Human T-cell lymphotropic virus type I (HTLVI) positive need consent of Principal Investigator and determination that this is the best donor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Richard E. Champlin
- Organization
- MDAnderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Richard E. Champlin, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- 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
September 1, 2001
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
August 10, 2012
Results First Posted
August 7, 2012
Record last verified: 2012-08