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-. 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

-. 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

predetermined dose, intravenously, a predetermined times per cycle Given in both pre stem cell and post stem cell cycles

FLUDARABINE

◦Cyclophosphamide predetermined dose, predetermined number of times in Given in pre-stem cell Regimen #1 Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion

CYCLOPHOSPHAMIDE

Total body irradiation (TBI) once per cycle.

Melphalan, infusion, determined dosage, once per cycle

Sirolimus: Predetermined dosage, predetermined number of time in cycle, oral: Please note that doses of sirolimus can be adjusted at the treating physician's discretion given the multiple drugs and other situations which affect its metabolism

◦Mycophenolate mofetil, oral or iv(predetermined dose or IV TID (based upon actual body weight), at predetermined times per cycle

Mycophenolate mofetil

IV, predetermined dose, weekly to 6 total doses

RGI-2001

◦Given in Post Stem Cell cycle of Regimen #1 and #2 Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion

Zachariah DeFilipp, MD

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

* This is a pilot study in subjects undergoing reduced-intensity haploidentical peripheral blood stem cell transplantation who will receive graft-versus-host disease prevention with post-transplant cyclophosphamide, followed by sirolimus, mycophenolate mofetil, and RGI-2001.
* The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* The standard of care drugs of fludarabine, cyclophosphamide, melphalan, radiation, sirolimus, and mycophenolate mofetil are all FDA approved.

  * Eligible Participants will be placed in 1 of 2 groups, per physicians discretion:
  * Regimen #1 :

    * Before stem cell transplant:Fludarabine + Cyclophosphamide + Radiation
    * After stem cell transplant: Cyclophosphamide + Sirolimus +Mycophenolate mofetil + RGI-2001
  * Regimen #2

    * Before stem cell transplant: fludarabine + melphalan + radiation
    * After stem cell transplant: cyclophosphamide + sirolimus +Mycophenolate mofetil + RGI-2001
* A total of 20 participants will be enrolled to this trial
* The U.S. Food and Drug Administration (FDA) has not approved RGI-2001 as a treatment for any disease.

Haplo Peripheral Blood Sct In GVHD Prevention

Reduced Intensity Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Sirolimus/Mycophenolate Mofetil/RGI-2001 Based GVHD Prevention: a Pilot Study

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to, please contact the Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

(absolute neutrophil count \> 500/uL and ≥ 90% donor cell chimerism)

The regimen will be considered as safe if 100d NRM rate is \<=5%, and not safe if 100d NRM rate is ≥25%.

Regimmune Corporation

Zachariah Michael DeFilipp

Sponsor Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Haplo Peripheral Blood Sct In GVHD Prevention	NCT04473911	GVHD AML ALL MDS MPN CMML Hodgkin Lymphom... Non Hodgkin Lym... Blood Stem Cell... Graft Vs Host D... Acute Myeloid L... Acute Lymphobla... Myelodysplastic... Myeloproliferat... Chronic Myelomo... Chemosensitive ...	FLUDARABINE CYCLOPHOSPHAMID... TBI Melphalan Sirolimus Mycophenolate m... RGI-2001 CYCLOPHOSPHAMID...	18 Years - 80 Years	Massachusetts General Hospital
Haplo Peripheral Blood Sct In GVHD Prevention	NCT04473911	GVHD AML ALL MDS MPN CMML Hodgkin Lymphom... Non Hodgkin Lym... Blood Stem Cell... Graft Vs Host D... Acute Myeloid L... Acute Lymphobla... Myelodysplastic... Myeloproliferat... Chronic Myelomo... Chemosensitive ...	FLUDARABINE CYCLOPHOSPHAMID... TBI Melphalan Sirolimus Mycophenolate m... RGI-2001 CYCLOPHOSPHAMID...	18 Years - 80 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for chemosensitive hodgkin lymphoma