Loading clinical trials...

Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies

A Phase II Study Evaluating the Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies

NCT02639559•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling and volunteer unrelated donors. Unfortunately, this process requires four to six days of G-CSF injection and can be associated with side effects, most notably bone pain and rarely splenic rupture. BL-8040 is given as a single SC injection, and collection of cells occurs on the same day as BL-8040 administration. This study will evaluate the safety and efficacy of this novel agent for hematopoietic progenitor cell mobilization and allogeneic transplantation based on the following hypotheses: * Healthy HLA-matched donors receiving one injection of BL-8040 will mobilize sufficient CD34+ cells (at least 2.0 x 10\^6 CD34+ cells/kg recipient weight) following no more than two leukapheresis collections to support a hematopoietic cell transplant. * The hematopoietic cells mobilized by SC BL-8040 will be functional and will result in prompt and durable hematopoietic engraftment following transplantation into HLA-identical siblings with advanced hematological malignancies using various non-myeloablative and myeloablative conditioning regimens and regimens for routine GVHD prophylaxis. * If these hypotheses 1 and 2 are confirmed after an interim safety analysis of the data, then the study will continue and include recruitment of haploidentical donors.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age 18 to 70 years of age.
•ECOG performance status of 0 or 1.
•PART 1: Donor must be a 5/6 or 6/6 HLA-matched sibling willing to donate PBSC for transplant.
•PART 2: Donor must be a 5/6 or 6/6 HLA-matched sibling or 3/6 or 4/6 HLA haploidentical donor willing to donate PBSC for transplant. Haploidentical donors will be allowed to participate upon investigator decision and based on the data reached from 5/6 or 6/6 HLA matched transplant done during Part 1 of the study.
•Adequate organ function defined by:
•* serum creatinine within normal limits or a minimum creatinine clearance (CrCl) value of ≥ 60 ml/min calculated using the Modification of Diet in Renal Disease (MDRD) Study equation
•* AST, ALT and total bilirubin ≤ 2x institutional upper limit of normal.
•Women of childbearing potential and men must agree to use adequate contraception with two different forms, including one barrier method, during participation in the study and for 2 weeks following dosing with BL-8040. Abstinence is acceptable if this is the established and preferred contraception for the subject.
•Female subjects must have a negative urine or serum pregnancy test within 10 days prior to taking study medication if of childbearing potential or must be of non-childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. Non-childbearing potential is defined as:
•-≥ 45 years of age and has not had menses for \> 2 years
+25 more criteria

Exclusion Criteria

•Received any investigational agent within 30 days and/or 5 half-lives (of the other investigational agent), whichever is longer, of receiving BL-8040.
•Active HIV or hepatitis B or C infection
•Pregnant or breastfeeding.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Known allergy or hypersensitivity to any of the test compounds, materials, or contraindication to test products.
•Any malignancies in the 2 years prior to baseline, excluding: basal cell carcinoma, in situ malignancy, low-risk prostate cancer, cervix cancer after curative therapy.
•A comorbid condition which, in the view of the investigators, renders the subject at high risk from treatment complications.
•Recipient must not have received any investigational drug within 30 days of starting conditioning treatment.
•Pregnant or breastfeeding.
•Active HIV or hepatitis B or C infection.
+1 more criteria

Locations (3)

Northside Hospital Cancer Institute

Atlanta, Georgia, United States

Washington University School of Medicine

St Louis, Missouri, United States

Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

March 31, 2016

Primary Completion Date

April 12, 2018

Completion Date

April 7, 2023

Last Updated

November 7, 2023

Enrollment

ACTUAL participants

Conditions

Acute Myelogenous LeukemiaAcute Lymphoblastic LeukemiaChronic Myelogenous LeukemiaNon-Hodgkin's LymphomaNon-Hodgkin LymphomaHodgkin DiseaseHodgkins DiseaseHodgkin's DiseaseMultiple MyelomaMyelodysplastic SyndromeMyeloproliferative Neoplasm

Interventions

BL-8040

DRUG

Leukapheresis

PROCEDURE

Hematopoietic cell transplant

PROCEDURE

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

NCT05376111

T-cell Acute Lymphoblastic LeukemiaRecruiting

View study

RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399

Acute Myeloid LeukemiaAcute Lymphoblastic Leukemia+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies

Inclusion Criteria

Exclusion Criteria

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

Venetoclax Basket Trial for High Risk Hematologic Malignancies