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Alkylating agents

Stem Cell Transplant for Blood Cancers

Phase 1

Recruiting

Led By Everett Meyer, MD,PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial found that RIC followed by a match aploidentical donor peripheral blood stem cell transplantation can be a feasible and effective treatment for older adults or those patients that are otherwise unfit for myeloablative conditioning.

Who is the study for?

This trial is for adults aged 18-75 with various advanced blood cancers, including different types of leukemia and myelodysplastic syndromes. Participants must be in remission or have minimal disease, match specific donor criteria for stem cell transplant, and have good heart, lung, kidney function. Pregnant women and those with active infections or certain viruses are excluded.Check my eligibility

What is being tested?

The study tests a reduced intensity conditioning regimen followed by a stem cell transplant from partially matched donors to treat blood cancers. It includes T-cell depletion using the CliniMACS system and medications like Fludarabine, Melphalan, Tacrolimus to prepare the body for transplantation.See study design

What are the potential side effects?

Potential side effects include weakened immune system leading to increased infection risk; reactions related to infusion; organ damage due to chemotherapy drugs; complications from stem cell transplant such as graft-versus-host disease where donor cells attack the patient's body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the GVHD-free relapse-free survival (GRFS) post-HCT ( Arm-A)

Determine the overall survival (OS) post-HCT ( Arm-B)

Donor CD3 chimerism at Day+60 post-HCT

+2 more

Secondary outcome measures

Acute GVHD (all grades)

Chronic GVHD (limited or extensive)

Disease-free survival (DFS)

+6 more

Other outcome measures

Incidence of serious infections (grade 2 and greater)

Time to Neutrophil engraftment

Time to Platelet engraftment

Trial Design

6Treatment groups

Experimental Treatment

Group I: Arm C2: 7/8 mismatched related/unrelated donor transplantationExperimental Treatment7 Interventions

Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant: Fludarabine (160 mg/m2) Thiotepa (5 mg/kg) TBI (2-3 Gy) All enrolled subjects will receive GVHD prophylaxis with tacrolimus and ruxolitinib.

Group II: Arm C1:7/8 mismatched related/unrelated donor transplantation (closed)Experimental Treatment7 Interventions

Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant: Fludarabine (160 mg/m2) Thiotepa (10 mg/kg) TBI (4 Gy) All enrolled subjects will receive GVHD prophylaxis with tacrolimus and mycophenolate mofetil (MMF).

Group III: Arm B: Haploidentical transplantation (closed)Experimental Treatment8 Interventions

Subjects without an identified matched related or matched unrelated donor will receive a haploidentical transplantation with reduced intensity preparative conditioning: -. Fludarabine (160 mg/m2) Melphalan (100 mg/m2 TBI (4Gy) Patients will receive GVHD prophylaxis with post-transplant cyclophosphamide and tacrolimus.

Group IV: Arm A3: Fully (8/8) matched related/unrelated donor transplantationExperimental Treatment6 Interventions

Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant: Fludarabine (160 mg/m2) Thiotepa (5 mg/kg) TBI (2-3 Gy). All enrolled subjects will receive GVHD prophylaxis with single-agent tacrolimus.

Group V: Arm A2: Fully matched (8/8) related/unrelated donor transplantationExperimental Treatment6 Interventions

Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant: Fludarabine (160 mg/m2) Thiotepa (10 mg/kg) TBI (4Gy) All enrolled subjects will receive GVHD prophylaxis with single-agent tacrolimus.

Group VI: Arm A1: Matched related/matched unrelated donor transplantation (closed)Experimental Treatment6 Interventions

Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant:. Fludarabine (160 mg/m2) Melphalan (50 mg/m2) TBI (4Gy) All enrolled subjects will receive GVHD prophylaxis with single-agent tacrolimus.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1140

Mycophenolate Mofetil (MMF)

2000

Completed Phase 4

~710

Thiotepa

2008

Completed Phase 3

~2210

Fludarabine

2012

Completed Phase 3

~1100

Melphalan

2008

Completed Phase 3

~1500

Tacrolimus

2011

Completed Phase 4

~4740

Cyclophosphamide

1995

Completed Phase 3

~3770

Plerixafor

2011

Completed Phase 3

~720

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Orca Biosystems, Inc.Industry Sponsor

5 Previous Clinical Trials

673 Total Patients Enrolled

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,310 Total Patients Enrolled

Everett Meyer, MD,PhDPrincipal InvestigatorStanford Universiy

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05088356 — Phase 1

Hematologic Malignancies Research Study Groups: Arm C1:7/8 mismatched related/unrelated donor transplantation (closed), Arm A1: Matched related/matched unrelated donor transplantation (closed), Arm B: Haploidentical transplantation (closed), Arm A2: Fully matched (8/8) related/unrelated donor transplantation, Arm A3: Fully (8/8) matched related/unrelated donor transplantation, Arm C2: 7/8 mismatched related/unrelated donor transplantation

Hematologic Malignancies Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05088356 — Phase 1

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05088356 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other peer-reviewed trials that utilize Filgrastim granulocyte colony-stimulating factor (G-CSF)?

"At this moment, there are 1140 Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent clinical trials underway with 206 in Phase 3. Many of these medical studies are based in Philadelphia, Pennsylvania, but there are 31564 locations running trials for Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent."

Answered by AI

Does this research project have age restrictions?

"This study requires that participants are over 18 and younger than 75."

Answered by AI

Has the FDA given their thumbs up to Filgrastim granulocyte colony-stimulating factor (G-CSF)?

"Given that Phase 1 trials have limited data to support safety and efficacy, our team rates Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent as a 1."

Answered by AI

Why is Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent a common medication?

"Filgrastim granulocyte colony-stimulating factor (G-CSF) is an effective treatment for dermatitis, atopic, multiple sclerosis, and leukemia, myelocytic, acute."

Answered by AI

What are the benefits that researchers hope to achieve with this study?

"The primary outcome of this clinical trial, which will be measured over the course of baseline, day +30, 60, 90, 180, year 1 and year 2 is to The incidence and timing of primary graft failure. Secondary objectives include Steroid-refractory acute GVHD which is defined as Steroid refractory acute GVHD will be defined as per the EBMT-NIH-CIBMTR Task Force position statement, Acute GVHD (all grades) which is defined as Acute GVHD (all grades) will be reported, and Non-relapse mortality (NRM)"

Answered by AI

Are researchers currently looking for participants in this trial?

"The official website for this clinical trial shows that it is still recruiting patients. This trial was first announced on September 7th, 2021 and was edited October 19th, 2022."

Answered by AI

Could I be a part of this research project if I qualify?

"This study is seeking 24 participants aged 18-75 who have myelodysplastic syndromes. Eligible participants must also meet the following criteria: histopathologically-confirmed acute myeloid, lymphoid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or beyond first complete remission (CR1) without the presence of minimal residual disease; not in morphologic CR with bone marrow infiltration by leukemic blasts of ≤10%; or in morphologic CR with evidence of minimal residual disease positivity by either multiparametric flow cytometric analysis or by"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft

2021. "Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05088356.

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