Cord Blood Transplant With OTS for the Treatment of HIV Positive Hematologic Cancers

STATUS

Recruiting
End date

Dec 31, 2025
participants needed

10
sponsor

Fred Hutchinson Cancer Center

Send

Updated on 11 August 2022

See if I qualify

cancer

remission

myeloid leukemia

total body irradiation

fludarabine

hematologic malignancy

blast crisis

anemia

imatinib

cyclophosphamide

immunodeficiency

myelodysplasia

umbilical cord blood transplantation

flow cytometry

carbon monoxide

ejection fraction

antiretroviral

antiretroviral therapy

leukemia

thiotepa

shortening fraction

serum bilirubin level

blast cells

tumor cells

HIV Vaccine

pancytopenia

bone marrow failure

Summary

This phase II trial studies the side effects of a cord blood transplant using OTS and to see how well it works in treating patients with human immunodeficiency virus (HIV) positive hematologic (blood) cancers. After a cord blood transplant, the immune cells, including white blood cells, can take a while to recover, putting the patient at increased risk of infection. OTS consists of blood stem cells that help to produce mature blood cells, including immune cells. Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total body irradiation is a type of whole-body radiation. Giving chemotherapy and total-body irradiation before a cord blood transplant with OTS may help to kill any cancer cells that are in the body and make room in the patient's bone marrow for new stem cells to grow and reduce the risk of infection.

Description

OUTLINE: Patients are assigned to 1 of 2 regimens.

REGIMEN A: Patients receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive umbilical cord blood-derived hematopoietic CD34-positive progenitor cells IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.

REGIMEN B: Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI once daily (QD) on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive umbilical cord blood-derived hematopoietic CD34-positive progenitor cells IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28, 80, and 180 days, and then at 1 and 2 years.

Details

Condition	Acute Erythroid Leukemia, Acute Lymphoblastic Leukemia, Acute Megakaryoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Non-Hodgkin Lymphoma, Refractory Anemia
Treatment	cyclophosphamide, Fludarabine, Total-Body Irradiation, Umbilical Cord Blood Transplantation, thiotepa, Cellular Therapy
Clinical Study Identifier	NCT04083170
Sponsor	Fred Hutchinson Cancer Center
Last Modified on	11 August 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Treatment with combination antiretroviral therapy (cART) for at least 1 month before enrollment
	Viral load < 5000 copies/ml plasma on cART
	Disease criteria
	Acute myeloid leukemia
	High risk in first complete remission (CR1), >= 2 cycles to obtain complete remission (CR), erythroblastic or megakaryocytic leukemia; >= in second complete remission (CR2)
	All patients must be in CR as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of >= 15%
	Patients for whom adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible. Specimen for morphologic assessment, including possible repeat procedures will be obtained (as possible). These patients must be discussed with the lead principal investigator, Filippo Milano prior to enrollment
	Acute lymphoblastic leukemia
	High risk CR1 (for example, but not limited to: t(9;22), t(1;19), t(4;11) or other mixed-lineage leukemia [MLL] rearrangements, hypodiploid); greater than 1 cycle to obtain CR; >= CR2
	All patients must be in CR as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of >= 15%
	Patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible. Specimen for morphologic assessment, including possible repeat procedures will be obtained (as possible). These patients must be discussed with the lead principal investigator, Filippo Milano prior to enrollment
	Chronic myelogenous leukemia excluding refractory blast crisis. To be eligible in
	Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or high risk (i.e., refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEBt]) or refractory anemia with severe pancytopenia or high-risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology
	first chronic phase (CP1) patient must have failed or be intolerant to
	imatinib mesylate
	Other hematologic malignancy such as non-Hodgkin lymphomas. Fred Hutch site: These patients must be presented at Patient Care Conference (PCC) prior to enrollment, given potential competing eligibility on auto-transplant protocols. Participating centers: These patients must be discussed with the lead principal investigator, Filippo Milano prior to enrollment
	Karnofsky (>= 16 years old) >= 70%
	Lansky (< 16 years old) >= 50%
	Adults: Calculated creatinine clearance must be > 60 mL and serum creatinine =< 2 mg/dL
	Children (< 18 years old): Calculated creatinine clearance must be > 60 mL/min
	Total serum bilirubin must be < 3 mg/dL
	Transaminases must be < 3 x the upper limit of normal
	Diffusion capacity of the lung for carbon monoxide (DLCO) corrected > 50% normal or for pediatric patients in whom DLCO cannot be measured has adequate pulmonary function
	Left ventricular ejection fraction > 45% OR
	Shortening fraction > 26%
	Ability to understand and the willingness to sign a written informed consent document (adult subject or parent/legal guardian of minor subject)
Exclusion Criteria
	Uncontrolled viral or bacterial infection at the time of study enrollment
	Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval
	Pregnant or breastfeeding
	Prior myeloablative transplant within the last 6 months
	Extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation
	Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy. Diagnostic lumbar puncture to be performed

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

cancer

remission

myeloid leukemia

total body irradiation

fludarabine

hematologic malignancy

umbilical cord blood transplantation

antiretroviral therapy

leukemia

thiotepa

shortening fraction

serum bilirubin level

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Edit Delete

Added by •

•

Private

Edit Delete

Reply by • • Private

Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

Enter the passcode

The passcode will expire in None.

Cord Blood Transplant With OTS for the Treatment of HIV Positive Hematologic Cancers