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LeukemiaPhase 4NCT02784561

Study of Busulfan and FLAG Conditioning Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation

A Phase 4 study testing Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd), Cytarabine(Actavis Italy S.p.A) and Fludarabine (Bayer) in people with Leukemia, run by Chinese PLA General Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine the safety and efficacy of Busulfan/FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor) Conditioning Regimen in Patients with Relapsed/refractory Acute Leukemia undergoing allogeneic peripheral blood stem cell transplantation. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Leukemia
What is being tested?
Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd), Cytarabine(Actavis Italy S.p.A) and Fludarabine (Bayer)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
Jul 2016to Jul 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • relapsed/refractory acute leukemia regardless of cytogenetics
  • All patients should aged 12 to 65 years
  • Have matched sibling donors, ≥8/10 HLA(human leukocyte antigen) matched unrelated donors or haploidentical donors
  • Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases

Who cannot join

  • Patients aged less than 12 years old
  • Patients with any uncontrolled infections or with severe pulmonary, renal, hepatic or cardiac diseases
  • Acute myeloid leukemia patients with t (15;17)

Trial locations and contacts

No sites are listed yet.

Daihong Liu, Doctor contact

86-13681171597

daihongrm@163.com

Liping Dou, Doctor contact

86-13681207138

lipingruirui@163.com

About this study

Official title: Safety and Efficacy Study of Busulfan/FLAG Conditioning Regimen in Patients With Relapsed/Refractory Acute Leukemia Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

The purpose of this study is to determine the safety and efficacy of Busulfan/FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor) Conditioning Regimen in Patients with Relapsed/refractory Acute Leukemia undergoing allogeneic peripheral blood stem cell transplantation.

Read the detailed description

Allogeneic hematopoietic stem cell transplantation (allo-SCT) is the only way to cure relapsed/refractory acute leukemia. Busulfan/Cyclophosphamide (BuCy, Cytarabine, Busulfan, Cyclophosphamide) has been a classical conditioning regimen for allo-SCT. Substitution of Cyclophosphamide in the BuCy regimen with Fludarabine (BuF) resulted in reduced toxicity and similar efficacy. FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor) is a chemotherapy regimen that has been proved to be effective for relapsed/refractory acute leukemia as salvage therapy. To reduce the relapse and improve the survival of those patients with relapsed/refractory acute leukemia who receive allo-SCT, the novel conditioning regimen consisting of Busulfan/FLAG was developed. The combination of Bu and FLAG without interval shortens the duration of conditioning and the pneutropenic period of the patient compared with successive administration of FLAG followed with BuF. In addition, regarding the established safety and efficacy of BuF and FLAG, it is reasonable to expect similar safety and enhanced antileukemic efficacy for Bu/FLAG compared with BuF. In this study, the safety and efficacy of this regimen in patients with relapsed/refractory acute leukemia undergoing allogeneic peripheral blood stem cell transplantation was investigated.

Conditions
Leukemia
Being tested
Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd), Cytarabine(Actavis Italy S.p.A), Fludarabine (Bayer), granulocyte colony-stimulating factor (KirinKunpeng), rabbit ATG（Sanofi/Genzyme）
Keywords
allogeneic peripheral blood stem cell transplantation, conditioning regimen, acute leukemia, relapsed/refractory
Medical subject headings
Leukemia, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)Drug

    Also called Myleran, Busulfex

    busulfan (3.2 mg/kg/day intravenously [i.v.], days -10 to -8)

  • Cytarabine(Actavis Italy S.p.A)Drug

    Also called Ara-C

    cytarabine (1.6 g/m2/day, days -7 to -3)

  • Fludarabine (Bayer)Drug

    Also called fludarabine phosphate (Fludara)

    fludarabine (30 mg/m2, day -7 to -3),

  • granulocyte colony-stimulating factor (KirinKunpeng)Drug

    Also called G-CSF（granulocyte colony-stimulating factor ）

    granulocyte colony-stimulating factor (5 ug/kg, day -8 to granulocyte recovery)

  • rabbit ATG（Sanofi/Genzyme）Drug

    Also called Thymoglobuline

    ATG; thymoglobuline, rabbit;2.5 mg/kg/day, days -5 to -2

Study groups in NCT02784561
Study groupRoleWhat they receive
Busulfan/FLAG conditioning regimenExperimentalAll recipients in this arm received the conditioning regimen consisting of Busulfan/FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor). The conditioning regimen for peripheral blood stem cell transplantation consisted of busulfan (3.2 mg/kg/ day intravenously [i.v.], days -10 to -8), fludarabine (30 mg/m2, day -7 to -3), cytarabine (1.6 g/m2/day, days -7 to -3), granulocyte colony-stimulating factor (5 ug/ kg, day -8 to -3). ATG (Thymoglobuline, rabbit) for haploidentical and matched unrelated donors transplantation recipients was used on 2.5 mg/kg/d from days -5 to -2).
Receives: Drug: Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd); Drug: Cytarabine(Actavis Italy S.p.A); Drug: Fludarabine (Bayer); Drug: granulocyte colony-stimulating factor (KirinKunpeng); Drug: rabbit ATG（Sanofi/Genzyme）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria

    Measured: two years

Secondary outcomes (5)

  1. Rate of Complete Remission as assessed by NCCN (National Comprehensive Cancer Network )criteria

    Measured: 30 days

  2. DFS(disease-free survival )

    Measured: two years

  3. TRM(treatment-related mortality )

    Measured: two years

  4. Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)

    Measured: three months

  5. Number of participants with Regimen-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJul 2019 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02784561
Sponsor's protocol ID
81370666-2
Status last verified
May 2016
First submitted
17 May 2016
Last updated
27 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Forman SJ, Rowe JM. The myth of the second remission of acute leukemia in the adult. Blood. 2013 Feb 14;121(7):1077-82. doi: 10.1182/blood-2012-08-234492. Epub 2012 Dec 14.

    PubMed 23243288

  • Tang W, Fan X, Wang L, Hu J. Busulfan and fludarabine conditioning regimen given at hematological nadir of cytoreduction fludarabine, cytarabine, and idarubicin chemotherapy in patients with refractory acute myeloid leukemia undergoing allogeneic stem cell transplantation: a single arm pilot consort study. Medicine (Baltimore). 2015 Apr;94(15):e706. doi: 10.1097/MD.0000000000000706.

    PubMed 25881847

  • Middeke JM, Herbst R, Parmentier S, Bug G, Hanel M, Stuhler G, Schafer-Eckart K, Rosler W, Klein S, Bethge W, Bitz U, Buttner B, Knoth H, Alakel N, Schaich M, Morgner A, Kramer M, Sockel K, von Bonin M, Stolzel F, Platzbecker U, Rollig C, Thiede C, Ehninger G, Bornhauser M, Schetelig J. Clofarabine salvage therapy before allogeneic hematopoietic stem cell transplantation in patients with relapsed or refractory AML: results of the BRIDGE trial. Leukemia. 2016 Feb;30(2):261-7. doi: 10.1038/leu.2015.226. Epub 2015 Aug 18.

    PubMed 26283567

  • Fu H, Xu L, Liu D, Zhang X, Liu K, Chen H, Wang Y, Han W, Han T, Huang X. Late-onset hemorrhagic cystitis after haploidentical hematopoietic stem cell transplantation in patients with advanced leukemia: differences in ATG dosage are key. Int J Hematol. 2013 Jul;98(1):89-95. doi: 10.1007/s12185-013-1350-8. Epub 2013 Apr 30.

    PubMed 23632950

  • Wang Y, Liu QF, Xu LP, Liu KY, Zhang XH, Ma X, Fan ZP, Wu DP, Huang XJ. Haploidentical vs identical-sibling transplant for AML in remission: a multicenter, prospective study. Blood. 2015 Jun 18;125(25):3956-62. doi: 10.1182/blood-2015-02-627786. Epub 2015 May 4.

    PubMed 25940714

  • Sun Y, Beohou E, Labopin M, Volin L, Milpied N, Yakoub-Agha I, Piemontese S, Polge E, Houhou M, Huang XJ, Mohty M, Nagler A, Gorin NC; Acute Leukemia Working Party of the EBMT. Unmanipulated haploidentical versus matched unrelated donor allogeneic stem cell transplantation in adult patients with acute myelogenous leukemia in first remission: a retrospective pair-matched comparative study of the Beijing approach with the EBMT database. Haematologica. 2016 Aug;101(8):e352-4. doi: 10.3324/haematol.2015.140509. Epub 2016 Apr 14. No abstract available.

    PubMed 27081180

  • Chang YJ, Huang XJ. Haploidentical stem cell transplantation: anti-thymocyte globulin-based experience. Semin Hematol. 2016 Apr;53(2):82-9. doi: 10.1053/j.seminhematol.2016.01.004. Epub 2016 Jan 18.

    PubMed 27000731

  • Wang Y, Wu DP, Liu QF, Qin YZ, Wang JB, Xu LP, Liu YR, Zhu HH, Chen J, Dai M, Huang XJ. In adults with t(8;21)AML, posttransplant RUNX1/RUNX1T1-based MRD monitoring, rather than c-KIT mutations, allows further risk stratification. Blood. 2014 Sep 18;124(12):1880-6. doi: 10.1182/blood-2014-03-563403.

    PubMed 25082877

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd), Cytarabine(Actavis Italy S.p.A) and Fludarabine (Bayer) in people with Leukemia, run by Chinese PLA General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daihong Liu, Doctor (86-13681171597, daihongrm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02784561, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.

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