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Alkylating agents

Cyclophosphamide + Bortezomib + Abatacept for Graft-versus-Host Disease

Q: How many participants are actively engaged in this research initiative?

Confirmed. Clinicaltrials.gov holds the record that this clinical trial is actively recruiting, beginning from March 13th 2022 and last updated on March 24th 2022. They are attempting to source 74 participants at one particular site.

Q: Does this study accommodate participants over the age of seventy-five?

According to the requirements for entry into this clinical trial, an individual must be aged 18 or over and no older than 100.

Q: Who meets the criteria for joining this research project?

For this clinical trial, 74 adults who have been diagnosed with graft vs host disease and meet the additional criteria (age ≥18 years, Karnofsky score ≥70%, no evidence of progressive bacterial, viral or fungal infection; creatinine clearance >50 mL/min/1.72m2; ALT &#x26; AST &#x3C;3x upper limit of normal total bilirubin &#x3C;2x ULN [except for Gilbert's syndrome]; alkaline phosphatase ≤250 IU/L; LVEF >45%; adjusted DLCO >50% and negative <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> serology) are required to be recruited within the age range

Phase 1 & 2

Recruiting

Led By Maher Abdul Hay, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

No evidence of progressive bacterial, viral, or fungal infection

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day +1 to day +730

Awards & highlights

Study Summary

This trial is for adult patients with blood cancers who are undergoing a stem cell transplant from a matched donor. The patients will receive standard care, as well as investigational drugs to help prevent GvHD.

Who is the study for?

Adults with blood cancers eligible for a stem cell transplant from a matched donor can join. They must have good organ function, no severe infections, and be willing to follow the study plan. Pregnant women, those with recent heart issues or another cancer within 3 years (with some exceptions), or who cannot consent are excluded.Check my eligibility

What is being tested?

The trial tests high-dose Cyclophosphamide, Bortezomib, and Abatacept as preventatives for Graft-versus-Host Disease after allogeneic HSCT in adults. It's a phase I-II study assessing the safety and effectiveness of these drugs post-transplant.See study design

What are the potential side effects?

Possible side effects include immune system suppression leading to increased infection risk, potential damage to organs like the liver and kidneys, allergic reactions to medication components, gastrointestinal issues, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any worsening infections.

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day +1 to day +730

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day +1 to day +730

This trial's timeline: 3 weeks for screening, Varies for treatment, and day +1 to day +730 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase I:Incidence Dose limiting toxicity (DLT)

Phase II: Grades II-IV Acute GvHD

Secondary outcome measures

Chronic GvHD

GvHD and relapse-free survival (GRFS)

Overall survival (OS)

+5 more

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00006184

100%

Injection site reaction

40%

Fatigue (asthenia, lethargy, malaise)

30%

Pruritus

30%

Platelets

30%

Chest pain (non-cardiac and non-pleuritic)

30%

Bone pain

30%

Headache

30%

Myalgia (muscle ache)

30%

SGPT (ALT)

30%

Abdominal pain or cramping

20%

Alkaline phosphatase

20%

Hypokalemia

20%

Dizziness/lightheadedness

20%

Arthralgia (joint pain)

20%

Hypomagnesemia

20%

Pain - Other

20%

Rash/desquamation

20%

Rigors/chills

20%

SGOT (AST)

10%

Hypoalbuminemia

10%

Hypocalcemia

10%

Hot flashes/flushes

10%

Hypophosphatemia

10%

Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)

10%

Lymphopenia

10%

Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis

10%

Dry skin

10%

Constipation

10%

Hypotension

10%

Joint, muscle, or bone (osseous)- Other (Calf cramping)

10%

Hypercalcemia

10%

Skin-Other (Drug reaction face, hands, neck)

10%

Hematologic-Other (Splenomegaly in donor-resolved)

10%

Dyspnea (shortness of breath)

10%

Rash/desquamation for BMT

10%

Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)

100%

80%

60%

40%

20%

Study treatment Arm

Donor - Vaccination Generation Group

Recipient - Chemotherapy Group

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with hematological malignanciesExperimental Treatment3 Interventions

Participants undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will receive a combination of cyclophosphamide, known commercially as Cytoxan®, abatacept, known as Orecia® and bortezomib commercially known as Velcade®, to reduce the rate of graft-versus-host disease (GvHD). These medications will be given for GvHD prevention during the transplant process.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

Abatacept

FDA approved

Bortezomib

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,493 Total Patients Enrolled

Maher Abdul Hay, MDPrincipal InvestigatorNYU Langone Health

1 Previous Clinical Trials

46 Total Patients Enrolled

Ahmad Al-Homsi, MDPrincipal InvestigatorNYU Langone Health

1 Previous Clinical Trials

23 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05289167 — Phase 1 & 2

Graft-versus-Host Disease Research Study Groups: Participants with hematological malignancies

Graft-versus-Host Disease Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05289167 — Phase 1 & 2

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05289167 — Phase 1 & 2

Frequently Asked Questions

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

How many participants are actively engaged in this research initiative?

"Confirmed. Clinicaltrials.gov holds the record that this clinical trial is actively recruiting, beginning from March 13th 2022 and last updated on March 24th 2022. They are attempting to source 74 participants at one particular site."

Answered by AI

Does this study accommodate participants over the age of seventy-five?

"According to the requirements for entry into this clinical trial, an individual must be aged 18 or over and no older than 100."

Answered by AI

Who meets the criteria for joining this research project?

"For this clinical trial, 74 adults who have been diagnosed with graft vs host disease and meet the additional criteria (age ≥18 years, Karnofsky score ≥70%, no evidence of progressive bacterial, viral or fungal infection; creatinine clearance >50 mL/min/1.72m2; ALT & AST <3x upper limit of normal total bilirubin <2x ULN [except for Gilbert's syndrome]; alkaline phosphatase ≤250 IU/L; LVEF >45%; adjusted DLCO >50% and negative HIV serology) are required to be recruited within the age range"

Answered by AI

What are the primary goals of this research project?

"This clinical trial's primary outcome, which will be assessed between Day +1 and Day+120, is the incidence of Grades II-IV Acute GvHD. Secondary objectives include GRFS (Graft versus Host Disease free Survival) evaluated until day +730; TRM (Treatment Related Mortality); and Primary Graft Failure from date of transplant to failure for all subjects who receive a transplant plus any prophylactic treatment."

Answered by AI

Is this research currently recruiting participants?

"Affirmative. The information accessible on clinicaltrials.gov reveals that this research endeavor, which was originally posted on March 13th 2022, is presently recruiting participants. There are 74 individuals to be enrolled from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High-Dose Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD) Following Allogenic Hematopoietic Stem Cell Transplantation (HSCT) Study

2022. "High-Dose Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD) Following Allogenic Hematopoietic Stem Cell Transplantation (HSCT) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05289167.

All > Gvhd > Velcade