Acute Myeloid LeukemiaPhase 2NCT02294552

Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT

A Phase 2 study testing Cyclophosphamide, Busulfan and Fludarabine monophosphate in people with Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Ivan S Moiseev at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Lymphoma
What is being tested?: Cyclophosphamide, Busulfan and Fludarabine monophosphate
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteRussia
Study dates: Oct 2014to Nov 2017
Phase: Phase 2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have an indication for allogeneic hematopoietic stem cell transplantation
Signed informed consent
Patients with a donor available. The donor and recipient must be identical at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is required for related donor. A minimum match of 8/10 is required for unrelated donor.
No second tumors
No severe concurrent illness

Who cannot join

Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50%
Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted
Respiratory distress >grade I
Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits
Creatinine clearance < 60 mL/min
Uncontrolled bacterial or fungal infection at the time of enrollment

Show all 10Show fewer

Requirement for vasopressor support at the time of enrollment
Karnofsky index <30%
Pregnancy
Somatic or psychiatric disorder making the patient unable to sign informed consent

Trial locations and contacts

1 site in 1 country.

Russia1 site

First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197089

Other trials in Russia

About this study

Official title: High-dose Post-transplantation Cyclophosphamide as Graft Versus-host Disease Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation

This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in patients with different risk of GVHD. The risk-adapted strategy involves using single-agent cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem cells and mismatched bone marrow.

Conditions: Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Lymphoma, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Immune System Diseases
Being tested: Cyclophosphamide, Busulfan, Fludarabine monophosphate, Tacrolimus, Mycophenolate mofetil
Keywords: Cyclophosphamide, Leukemia, Lymphoma, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Immunosuppressive Agents, Immune System Diseases, Busulfan, Fludarabine, Tacrolimus, Mycophenolate mofetil, Antineoplastic Agents, Alkylating, Myeloablative Agonists, Hematopoietic Stem Cell Transplantation, Allogeneic
Medical subject headings: Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Myelodysplastic Syndromes, Leukemia, Lymphocytic, Chronic, B-Cell, Immune System Diseases, Leukemia

What participants receive

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

CyclophosphamideDrug
BusulfanDrug
Fludarabine monophosphateDrug
TacrolimusDrug
Mycophenolate mofetilDrug
Allogeneic hematopoietic stem cell transplantationProcedure or surgery

Study groups in NCT02294552
Study group	Role	What they receive
Matched bone marrow graft	Experimental	Days -8 through -4: Busulfan 1 mg/kg po qid x 4 days Days -3 through -2: Cyclophosphamide 50mg/kg/day iv x 2 days Or Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -4 through -3: Busulfan 1 mg/kg po qid x 2 days Day 0: Infusion of unmanipulated graft Day +3 and +4: Cyclophosphamide 50 mg/kg/day iv Receives: Drug: Cyclophosphamide; Drug: Busulfan; Drug: Fludarabine monophosphate; Procedure: Allogeneic hematopoietic stem cell transplantation
Matched peripheral blood stem cells graft	Experimental	Days -8 through -4: Busulfan 1 mg/kg po qid x 4 days Days -3 through -2: Cyclophosphamide 50mg/kg/day iv x 2 days Or Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -4 through -3: Busulfan 1 mg/kg po qid x 2 days Day 0: Infusion of unmanipulated graft Day +3 and +4: Cyclophosphamide 50 mg/kg/day iv Days +5 through +35: Mycophenolate mofetil 30 mg/kg/day, maximum 2 g/day, iv or po x 30 days Days +5 through +120: Tacrolimus 0.03 mg/kg/day with further correction by concentration Receives: Drug: Cyclophosphamide; Drug: Busulfan; Drug: Fludarabine monophosphate; Drug: Tacrolimus; Drug: Mycophenolate mofetil; Procedure: Allogeneic hematopoietic stem cell transplantation
Mismatched peripheral blood stem cells or bone marrow graft	Experimental	Days -8 through -4: Busulfan 1 mg/kg po qid x 4 days Days -3 through -2: Cyclophosphamide 50mg/kg/day iv x 2 days Or Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -4 through -3: Busulfan 1 mg/kg po qid x 2 days Day 0: Infusion of unmanipulated graft Day +3 and +4: Cyclophosphamide 50 mg/kg/day iv Days +5 through +35: Mycophenolate mofetil 45 mg/kg/day, maximum 3 g/day, iv or po x 30 days Days +5 through +120: Tacrolimus 0.03 mg/kg/day with further correction by concentration Receives: Drug: Cyclophosphamide; Drug: Busulfan; Drug: Fludarabine monophosphate; Drug: Tacrolimus; Drug: Mycophenolate mofetil; Procedure: Allogeneic hematopoietic stem cell transplantation

What is being measured

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

Incidence of acute and chronic GVHD, requiring treatment
Measured: 365 days

Secondary outcomes (7)

Incidence of primary graft failure
Measured: 60 days
Non-relapse mortality analysis
Measured: 365 days
Overall survival analysis
Measured: 365 days
Event-free survival analysis
Measured: 365 days
Relapse rate analysis
Measured: 365 days
Toxicity based NCI CTC grades
Measured: 100 days
Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence
Measured: 100 days

Timeline

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

Oct 2014Nov 2017

First posted19 Nov 2014 (estimated)
Study startOct 2014
Primary completionNov 2016
Study completionNov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02294552
Sponsor's protocol ID: PTCy-2014
Status last verified: Jan 2018
First submitted: 30 Oct 2014
Last updated: 16 Jan 2018
Results posted: No
Data monitoring committee: No

Publications

Moiseev IS, Pirogova OV, Alyanski AL, Babenko EV, Gindina TL, Darskaya EI, Slesarchuk OA, Bykova TA, Chukhlovin AB, Pevtcov DE, Bondarenko SN, Afanasyev BV. Risk-adapted GVHD prophylaxis with post-transplantation cyclophosphamide in adults after related, unrelated, and haploidentical transplantations. Eur J Haematol. 2018 May;100(5):395-402. doi: 10.1111/ejh.13030. Epub 2018 Mar 1.
PubMed 29360184

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: High-dose Post-transplantation Cyclophosphamide as Graft Versus-host Disease Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT02294552
Acronym / sponsor ID: PTCy-2014
Conditions: Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Lymphoma, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Immune System Diseases
Keywords: Cyclophosphamide, Leukemia, Lymphoma, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Immunosuppressive Agents, Immune System Diseases, Busulfan
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Ivan S MoiseevUniversity, hospital or other
Study start: Oct 2014 (actual)
Primary completion: Nov 2016 (actual)
Study completion: Nov 2017 (actual)
First posted: 19 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Matched bone marrow graft	Experimental	Drug: Cyclophosphamide, Drug: Busulfan, Drug: Fludarabine monophosphate, Procedure: Allogeneic hematopoietic stem cell transplantationDays -8 through -4: Busulfan 1 mg/kg po qid x 4 days Days -3 through -2: Cyclophosphamide 50mg/kg/day iv x 2 days Or Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -4 through -3: Busulfan 1 mg/kg po qid x 2 days Day 0: Infusion of unmanipulated graft Day +3 and +4: Cyclophosphamide 50 mg/kg/day iv
Matched peripheral blood stem cells graft	Experimental	Drug: Cyclophosphamide, Drug: Busulfan, Drug: Fludarabine monophosphate, Drug: Tacrolimus, Drug: Mycophenolate mofetil, Procedure: Allogeneic hematopoietic stem cell transplantationDays -8 through -4: Busulfan 1 mg/kg po qid x 4 days Days -3 through -2: Cyclophosphamide 50mg/kg/day iv x 2 days Or Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -4 through -3: Busulfan 1 mg/kg po qid x 2 days Day 0: Infusion of unmanipulated graft Day +3 and +4: Cyclophosphamide 50 mg/kg/day iv Days +5 through +35: Mycophenolate mofetil 30 mg/kg/day, maximum 2 g/day, iv or po x 30 days Days +5 through +120: Tacrolimus 0.03 mg/kg/day with further correction by concentration
Mismatched peripheral blood stem cells or bone marrow graft	Experimental	Drug: Cyclophosphamide, Drug: Busulfan, Drug: Fludarabine monophosphate, Drug: Tacrolimus, Drug: Mycophenolate mofetil, Procedure: Allogeneic hematopoietic stem cell transplantationDays -8 through -4: Busulfan 1 mg/kg po qid x 4 days Days -3 through -2: Cyclophosphamide 50mg/kg/day iv x 2 days Or Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -4 through -3: Busulfan 1 mg/kg po qid x 2 days Day 0: Infusion of unmanipulated graft Day +3 and +4: Cyclophosphamide 50 mg/kg/day iv Days +5 through +35: Mycophenolate mofetil 45 mg/kg/day, maximum 3 g/day, iv or po x 30 days Days +5 through +120: Tacrolimus 0.03 mg/kg/day with further correction by concentration

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients must have an indication for allogeneic hematopoietic stem cell transplantation
Signed informed consent
Patients with a donor available. The donor and recipient must be identical at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is required for related donor. A minimum match of 8/10 is required for unrelated donor.
No second tumors
No severe concurrent illness

Key exclusion criteria (10 listed)

Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50%
Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted
Respiratory distress >grade I
Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits
Creatinine clearance < 60 mL/min

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cyclophosphamide	Drug	Matched bone marrow graft, Matched peripheral blood stem cells graft, Mismatched peripheral blood stem cells or bone marrow graft
Busulfan	Drug	Matched bone marrow graft, Matched peripheral blood stem cells graft, Mismatched peripheral blood stem cells or bone marrow graft
Fludarabine monophosphate	Drug	Matched bone marrow graft, Matched peripheral blood stem cells graft, Mismatched peripheral blood stem cells or bone marrow graft
Tacrolimus	Drug	Matched peripheral blood stem cells graft, Mismatched peripheral blood stem cells or bone marrow graft
Mycophenolate mofetil	Drug	Matched peripheral blood stem cells graft, Mismatched peripheral blood stem cells or bone marrow graft
Allogeneic hematopoietic stem cell transplantation	Procedure or surgery	Matched bone marrow graft, Matched peripheral blood stem cells graft, Mismatched peripheral blood stem cells or bone marrow graft

Primary outcome

Incidence of acute and chronic GVHD, requiring treatment
Time frame: 365 days

7 secondary outcomes

Incidence of primary graft failure
Time frame: 60 days
Non-relapse mortality analysis
Time frame: 365 days
Overall survival analysis
Time frame: 365 days
Event-free survival analysis
Time frame: 365 days
Relapse rate analysis
Time frame: 365 days
Toxicity based NCI CTC grades
Time frame: 100 days
Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence
Time frame: 100 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
Derived from this study: PubMed 29360184Moiseev IS, Pirogova OV, Alyanski AL, Babenko EV, Gindina TL, Darskaya EI, Slesarchuk OA, Bykova TA, Chukhlovin AB, Pevtcov DE, Bondarenko SN, Afanasyev BV. Risk-adapted GVHD prophylaxis with post-transplantation cyclophosphamide in adults after related, unrelated, and haploidentical transplantations. Eur J Haematol. 2018 May;100(5):395-402. doi: 10.1111/ejh.13030. Epub 2018 Mar 1.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boris V Afanasyev, MD, Prof. principal investigator

First Pavlov State Medical University of St. Petersburg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide, Busulfan and Fludarabine monophosphate in people with Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Ivan S Moiseev at 1 site in Russia.

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 5 inclusion and 10 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: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of acute and chronic GVHD, requiring treatment (time frame: 365 days). 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 NCT02294552, which also lists 1 linked publication.

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 16 Jan 2018.