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Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL

Primary Purpose

Acute B Lymphoblastic Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Fludarabine

About this trial

This is an interventional treatment trial for Acute B Lymphoblastic Leukemia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ages 18-55.
The patient was diagnosed as acute B-lymphoblastic leukemia, which was confirmed by bone marrow cell morphology, cytochemistry, immunotyping and chromosome examination, including acute chronic myelocytic leukemia, Ph-acute B-lymphoblastic leukemia, and acute B-lymphoblastic leukemia after CART treatment.
The diagnostic criteria for b-blastic leukemia in remission were: complete hematologic response (CR) with negative minimal residual lesions (MRD) after regular induction of remission chemotherapy, or complete hematologic response with negative MRD after CART treatment.
ECOG physical fitness status score ≤2.
All organs function normally and meet the following inspection standards:
A) Liver function ALT, AST and TBIL≤2 times the upper limit of normal value B) BUN and Cr of renal function ≤1.25 times the upper limit of normal value.
Have the following cardiac function conditions: ecg examination did not indicate any acute myocardial infarction, arrhythmia or atrioventricular block of degree I or above; Centerless incomplete function; No active rheumatic heart disease; There was no indication of cardiac enlargement on chest radiograph or physical examination.

(7) The patient had a qualified allogeneic hematopoietic stem cell transplantation donor, including haploid, myeloma and sibling.

8) The patient and its legal client have the desire and requirement for hematopoietic stem cell transplantation, and sign the informed consent, and are willing to and abide by the treatment plan, follow-up plan, laboratory examination, etc.

9) The donor meets the donation requirements-

Exclusion Criteria:

There are any contraindications for allogeneic hematopoietic stem cell transplantation.
Ph+ acute lymphoblastic leukemia
Serious damage of important organ functions, such as respiratory failure, heart failure, decompensated liver insufficiency, renal insufficiency, etc.
Pregnant or lactating women.
Those who are undergoing clinical trials of other drugs.
Patients suffering from other serious acute or chronic physical or mental diseases, or abnormal laboratory examination, which may affect the administration of study drugs and the researchers' judgment of the condition and interpretation of the test results, are not suitable to participate in the clinical trial.
The donor does not fit the conditions of the donor.

Sites / Locations

Shanghai General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

conditioning regimen with Malilane,cyclophosphamide and fludarabine

conditioning regimen with Malilane and cyclophosphamide

Arm Description

Malilane 3.2mg/kg/d *4d (-5,-4,-3,-2day) cyclophosphamide 25mg/kg/d*4d (-9-8,-7,-6 day) fludarabine 30mg/m2/d*4d (-9-8,-7,-6 day) Donor stem cells will be transfused at 0 days.

malilane 3.2mg/kg *4d (-5,-4,-3,-2day) cyclophosphamide 50mg/kg/d*2d (-2,-1day) Donor stem cells will be transfused at 0 days.

Outcomes

Primary Outcome Measures

RFS

Relapse-free survival

Secondary Outcome Measures

OS (OS).

overall survival

relapse rate

adverse event

Full Information

NCT ID

NCT05379569

First Posted

May 3, 2022

Last Updated

May 13, 2022

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05379569

Brief Title

Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL

Official Title

Shanghai General Hospital, Shanghai, Jiao Tong University School of Medicine

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 15, 2022 (Anticipated)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

Comparing the efficacy and safety of fludarabine-containing BFC conditioning regimen with traditional BuCy conditioning regimen in Acute B-cell lymphoblastic leukemia patients who treated with allogeneic hematopoietic stem cell transplantation, to establish a conditioning regimen for improving the survival rate of patients with B-cell ALL after transplantation. Acute B-cell lymphoblastic leukemia (B-ALL) is a hematologic malignancy . The incidence of B-All is higher in children than in adults, but more than 80% of children patients can be cured by chemotherapy, while the survival rate of adult patients is less than 40%. Recurrence or progression of the disease is the main reason affecting the survival of patients. Although CD19-targeted CAR T cell therapy is an effective salvage treatment for relapsed and refractory B-ALL, bridging allogeneic hematopoietic stem cell transplantation is required after remission. 1-year LFS and 1-year OS were 11.6% and 32% in patients without bridging grafts after CAR T. Allogeneic hematopoietic stem cell transplantation is an effective treatment for ALL. Before the transplant, patients receive high doses of chemotherapy plus or total body irradiation（TBI） to 'creation of space' ，immunosuppression and disease eradication. This is called conditioning regimen. Conditioning regimen plays a key role in reducing tumor load and diseaseconditioning regimen recurrence. Conditioning regimen for different diseases are different. Conditioning regimen are based on TBI and chemotherapy BuCy, with low TBI recurrence rate but high treatment-related mortality (TRM). BuCY chemotherapy had low TRM but high recurrence rate, so there was no difference in total OS. Therefore, it is of great clinical value to explore a conditioning regimenprogram. How to optimize the preconditioning program before transplantation, so as to reduce the recurrence rate and prolong the survival period of adult B-cell ALL patients after transplantation has become a issue that needs to be solved urgently in clinical practice. BFC (Malilane + fludarabine + cyclophosphamide) is the addition of fludarabine to BuCy (malilane + cyclophosphamide). The combination of fludarabine and cyclophosphamide has synergistic effect, which can better kill B lymphocyte, and can enhance the killing effect of pretreatment regimen on B lymphocyte tumor.

Detailed Description

This study was a prospective, randomized, controlled, single-center clinical study. A total of 142 patients eligible for the inclusion of acute B lymphoblastic leukemia were randomly divided into two groups: the experimental group (n = 71) and the control group (n = 71). The treatment group was given BFC conditioning regimen (fludalabine, marylan, cyclophosphamide), and the control group was given BuCY conditioning regimen (marylan, cyclophosphamide), and the patients were followed up to 1 year after transplantation. The 1-year disease-free survival rate of patients in the two groups was compared to evaluate whether increasing fludarabine could reduce the recurrence rate of patients after transplantation and thus improve the overall survival rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute B Lymphoblastic Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

conditioning regimen with Malilane,cyclophosphamide and fludarabine

Arm Type

Experimental

Arm Description

Malilane 3.2mg/kg/d *4d (-5,-4,-3,-2day) cyclophosphamide 25mg/kg/d*4d (-9-8,-7,-6 day) fludarabine 30mg/m2/d*4d (-9-8,-7,-6 day) Donor stem cells will be transfused at 0 days.

Arm Title

conditioning regimen with Malilane and cyclophosphamide

Arm Type

Active Comparator

Arm Description

malilane 3.2mg/kg *4d (-5,-4,-3,-2day) cyclophosphamide 50mg/kg/d*2d (-2,-1day) Donor stem cells will be transfused at 0 days.

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Other Intervention Name(s)

Malilane and cyclophosphamide

Intervention Description

The combination of fludarabine and cyclophosphamide has synergistic effect, which can better kill B lymphocyte, and can enhance the killing effect of pretreatment regimen on B lymphocyte tumor.

Primary Outcome Measure Information:

Title

RFS

Description

Relapse-free survival

Time Frame

one year

Secondary Outcome Measure Information:

Title

OS (OS).

Description

overall survival

Time Frame

one year

Title

Description

relapse rate

Time Frame

one year

Title

Description

adverse event

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages 18-55. The patient was diagnosed as acute B-lymphoblastic leukemia, which was confirmed by bone marrow cell morphology, cytochemistry, immunotyping and chromosome examination, including acute chronic myelocytic leukemia, Ph-acute B-lymphoblastic leukemia, and acute B-lymphoblastic leukemia after CART treatment. The diagnostic criteria for b-blastic leukemia in remission were: complete hematologic response (CR) with negative minimal residual lesions (MRD) after regular induction of remission chemotherapy, or complete hematologic response with negative MRD after CART treatment. ECOG physical fitness status score ≤2. All organs function normally and meet the following inspection standards: A) Liver function ALT, AST and TBIL≤2 times the upper limit of normal value B) BUN and Cr of renal function ≤1.25 times the upper limit of normal value. Have the following cardiac function conditions: ecg examination did not indicate any acute myocardial infarction, arrhythmia or atrioventricular block of degree I or above; Centerless incomplete function; No active rheumatic heart disease; There was no indication of cardiac enlargement on chest radiograph or physical examination. (7) The patient had a qualified allogeneic hematopoietic stem cell transplantation donor, including haploid, myeloma and sibling. 8) The patient and its legal client have the desire and requirement for hematopoietic stem cell transplantation, and sign the informed consent, and are willing to and abide by the treatment plan, follow-up plan, laboratory examination, etc. 9) The donor meets the donation requirements- Exclusion Criteria: There are any contraindications for allogeneic hematopoietic stem cell transplantation. Ph+ acute lymphoblastic leukemia Serious damage of important organ functions, such as respiratory failure, heart failure, decompensated liver insufficiency, renal insufficiency, etc. Pregnant or lactating women. Those who are undergoing clinical trials of other drugs. Patients suffering from other serious acute or chronic physical or mental diseases, or abnormal laboratory examination, which may affect the administration of study drugs and the researchers' judgment of the condition and interpretation of the test results, are not suitable to participate in the clinical trial. The donor does not fit the conditions of the donor.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yu Cai, MD

Phone

+86-13818583066

butterflymmyu@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xianmin Song, MD

Organizational Affiliation

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai General Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xianmin Song, M.D.

Phone

021-63240090

shongxm@139.com

First Name & Middle Initial & Last Name & Degree

Lianghong Fang, doctor

Phone

02158552006

fanghongliang@dashengbio.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL

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