NCT01596257

Brief Summary

The purpose of this study is to find out if getting a blood stem cell transplant with donor stem cells given over several days is better than getting a blood stem cell transplant with donor stem cells given over 1 day. We want to find out which procedure over will result in improved recovery of blood and immune function after transplant. When donor stem cells are given over various days in mice, the blood and immune system recovery is quicker.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P75+ for phase_2 leukemia

Timeline
Completed

Started May 2012

Longer than P75 for phase_2 leukemia

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

May 5, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 29, 2022

Completed
Last Updated

December 29, 2022

Status Verified

August 1, 2021

Enrollment Period

9.3 years

First QC Date

May 9, 2012

Results QC Date

August 29, 2022

Last Update Submit

December 1, 2022

Conditions

Leukemia

Keywords

CliniMACS-CD34 Reagent SystemAcute LeukemiaMyelodysplastic syndromeNon Hodgkins LymphomaHodgkins DiseaseMultiple Myeloma12-016

Outcome Measures

Primary Outcomes (1)

  • Median Time to Engraftment of Neutrophils

    Determine the effects of fractionated vs. bulk stem cell infusions on neutrophil recovery as defined by number of days with an absolute neutrophil count of less than 500 neutrophils per micro liter and time to an absolute neutrophil count (ANC) of 500. Determing the median time to ANC of \>/= 0.5 x 10\^9/L

    Up to 100 weeks

Secondary Outcomes (6)

  • Number of Participants Assessed for Toxicities

    2 years

  • Median Time to Platelet Engraftment

    Up to 365 days

  • Overall Survival

    24 months

  • Hematopoietic Function on Day 30

    30 days

  • Hematopoietic Function on Day 180

    180 days

  • +1 more secondary outcomes

Study Arms (2)

bulk SCT

ACTIVE COMPARATOR

Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months

Procedure: allogeneic hematopoietic stem cell transplantationDevice: CliniMACS

fractionated SCT

EXPERIMENTAL

Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months

Procedure: allogeneic hematopoietic stem cell transplantationDevice: CliniMACS

Interventions

allogeneic hematopoietic stem cell transplantationPROCEDURE

Undergo allogeneic hematopoietic stem cell transplant

bulk SCTfractionated SCT
CliniMACSDEVICE
bulk SCTfractionated SCT

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are considered candidates for an allogeneic stem cell transplantation as treatment for any of the following hematologic disorders:
  • Acute Leukemia
  • Myelodysplastic syndrome
  • Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic leukemia, or chronic myelogenous leukemia)
  • Non Hodgkins Lymphoma
  • Hodgkins Disease
  • Multiple Myeloma
  • Age includes from birth to \< 75 years old.
  • Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status \> 70%
  • Patients must have adequate organ function measured by:
  • Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 40%
  • Hepatic: \< 5x ULN ALT and \< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
  • Renal: serum creatinine \<1.5 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 40 ml/min (measured or calculated/estimated)
  • Pulmonary: asymptomatic or if symptomatic, DLCO \> 40% of predicted (corrected for hemoglobin).

You may not qualify if:

  • Female patients who are pregnant or breast-feeding.
  • Active viral, bacterial or fungal infection
  • Patient seropositive for HIV-I/II; HTLV -I/II
  • Presence of leukemia in the CNS
  • Candidate for a protocol of higher priority. For the purpose of this study, the following protocols will be considered of higher priority: 10-051
  • HLA compatible related or unrelated donor, (i.e. a fully matched unmanipulated grafts or 1-2 HLA allele disparate donor for CD34 selected grafts).
  • Meets criteria outlined in the FACT-approved SOP for "DONOR EVALUATION AND SELECTION FOR ALLOGENEIC TRANSPLANTATION" in the Blood and Marrow Transplant Program Manual, document E-1 see http://mskweb5.mskcc.org/intranet/html/80312.cfm
  • Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.
  • Wt \>25kg
  • Evidence of active infection (including urinary tract infection, or upper respiratory tract Infection) or viral hepatitis exposure (on screening), unless only HBS Ab+ and HBV DNA negative.
  • Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis.
  • Factors which place the donor at increased risk for complications from leukapheresis or GCSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy).
  • Pregnancy (positive serum or urine β-HCG) or breastfeeding. Women of childbearing age must avoid becoming pregnant while on the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLymphoma, Non-HodgkinHodgkin DiseaseMultiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Results Point of Contact

Title
Dr. Sergio Giralt, MD
Organization
Memorial Sloan Kettering Cancer Center
GiraltS@mskcc.org
646-608-3731

Study Officials

  • Sergio Giralt, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

May 5, 2012

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

December 29, 2022

Results First Posted

December 29, 2022

Record last verified: 2021-08

Locations

US(1)