RGI-2001 for Preventing GVHD in Blood Cancer

Recruiting in Palo Alto (17 mi)

Overseen byZachariah DeFilipp, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Zachariah Michael DeFilipp

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This research study is studying the RGI-2001 for preventing Graft-vs-Host Disease (GVHD) in people with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), chronic myelomonocytic leukemic (CMML), chemosensitive hodgkin lymphoma (HL), or Non-Hodgkin lymphoma (NHL).who will have a blood stem cell transplantation. * GVHD is a condition in which cells from the donor's tissue attack the organs. * RGI-2001 is an investigational treatment

Eligibility Criteria

Adults aged 18-80 with certain blood cancers (like AML, ALL, MDS, MPN, CMML) in remission or with low disease activity and those with chemosensitive Hodgkin's or Non-Hodgkin's lymphoma. Participants must be undergoing a specific type of stem cell transplant from a half-matched relative and have good heart, liver, kidney, and lung function.

Inclusion Criteria

My lung function tests are at least half of what is expected for someone my age and size.

I have been diagnosed with a blood cancer.

-- ALT, AST, and Alkaline Phosphatase < 5 x ULN

+14 more

Exclusion Criteria

Participants who are receiving any other investigational agents within 14 days prior to RGI-2001 dosing. Thus, participants must stop investigational agents by Day -9 prior to transplant.

I do not have any active infections needing treatment.

I do not have any severe illnesses that would stop me from following the study's requirements.

+4 more

Participant Groups

The trial is testing RGI-2001 to prevent Graft-vs-Host Disease (GVHD), which can occur after stem cell transplants when donor cells attack the recipient's body. It involves patients who are receiving transplants due to various hematological conditions.

2Treatment groups

Experimental Treatment

Group I: Regimen 2: Fludarabine, Melphalan, and TBIExperimental Treatment7 Interventions

-. Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. Two reduced intensity regimens will be allowed, according to the choice of the treating physician * Pre- stem cell transplant: * Fludarabine predetermined dose, intravenously 3 times per cycle * Melphalan, infusion, determined dosage, once per cycle * Total body irradiation (TBI) once per cycle. * Post stem cell transplant * Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion * Sirolimus: Predetermined dosage, predetermined number of time in cycle, oral: * Mycophenolate mofetil, oral or iv(predetermined dose or IV TID (based upon actual body weight), at predetermined times per cycle * RGI-2001: IV, predetermined dose, weekly to 6 total doses

Group II: Regimen 1: Fludarabine, Cyclophosphamide, and TBIExperimental Treatment6 Interventions

-. Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. Two reduced intensity regimens will be allowed, according to the choice of the treating physician * Pre- stem cell transplant: * Fludarabine predetermined dose, intravenously, 4 times per cycle * Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion * Total body irradiation (TBI) once during treatment cycle * Post stem cell transplant: * Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion * Sirolimus: Predetermined dosage, predetermined number of time in cycle, oral. * Mycophenolate mofetil, oral or iv(predetermined dose or IV TID (based upon actual body weight), at predetermined times per cycle * RGI-2001: IV, predetermined dose, weekly to 6 total doses