NCT00973804

Pilot Trial of Targeted Immune-Depleting Chemotherapy and Reduced-Intensity Matched Unrelated Double Cord Blood Transplant for the Treatment of Leukemias, Lymphomas, and Pre-Malignant Blood Disorders

Terminated Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing EPOCH-F/R in Leukemia in 4 participants. Terminated before completion.

Timeline

25 August 2009

Primary endpoint
20 May 2013

20 May 2013

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	25 August 2009
Primary completion	20 May 2013
Estimated completion	20 May 2013
Sites	1 location across United States

Drugs / interventions tested

• EPOCH-F/R — full drug profile →
• FLAG — full drug profile →
• Transplant Preparative Regimen (Flu/Cy/Mes) — full drug profile →
• GVHD Prophylaxis (tacrolimus and sirolimus) — full drug profile →
• Double Cord Blood Transplantation

Conditions studied

• Leukemia — all drugs for Leukemia →
• Non-Hodgkins Lymphoma — all drugs for Non-Hodgkins Lymphoma →
• Hodgkins Lymphoma — all drugs for Hodgkins Lymphoma →
• MDS — all drugs for MDS →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 69, any sex, with Leukemia or Non-Hodgkins Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* Allogeneic stem cell transplantation (SCT) has been used to treat many kinds of cancer or pre-cancerous conditions that develop in blood or immune system cells. Umbilical cord blood transplantation (UCBT) is a type of allogeneic transplant that is used when none of a patient s siblings are a match and an acceptable match cannot be identified from one of the bone marrow registries. Prior to receiving the cord blood stem cells, large doses of chemotherapy drugs and/or radiation have been traditionally used to eliminate most of the cancerous or abnormal cells from the recipient s system, along with most of his or her own stem cells and immune cells. Donor stem cells then replace the recipient s stem cells in the bone marrow, restoring normal blood production and immunity. In this way, an allogeneic SCT provides not only new blood cells but an entire new immune system.
* In the past, allogeneic SCT was performed with very high doses of chemotherapy and/or radiation to get rid of as much of the recipient s cancer as possible and prevent rejection of the treatment. However, intensive chemotherapy or radiation can cause serious side effects, including death. A newer method uses smaller, less toxic doses of chemotherapy and/or radiation before allogeneic SCT. In these reduced-intensity stem cell transplants, the recipient s stem cells and immunity are not completely eliminated, but they are weakened enough to help prevent the donor s cells from being rejected.

Objectives:

\- To study the safety and effectiveness of reduced-intensity stem cell transplants given with immune-depleting chemotherapy and umbilical cord blood provided by an unrelated donor.

Eligibility:

* Individuals between 18 and 69 years of age who have been diagnosed with any of a number of cancerous and pre-cancerous blood conditions, including lymphoma and leukemia.
* Participants must not have a potential donor sibling or a readily available unrelated donor identified through one of the bone marrow donor registries.

Design:

* Patients will be matched with at least two umbilical cords with an acceptable cell dose. The two frozen umbilical cord blood units will be sent to the NIH prior to the date of transplant.
* Patients will receive one, two, or three cycles of chemotherapy (based on the type of disease) to treat the disease and to weaken the immune system. Patients who already have a weakened immune system from other treatments will not receive this round of chemotherapy.
* Patients will then receive 4 days of reduced-intensity transplant chemotherapy (also called the conditioning regimen ) to prepare for the transplant.
* Two days after transplant chemotherapy, patients will receive the transplant, with the two umbilical cords infused one after the other on the same day. Patients will receive additional treatment to prevent complications.
* Patients will remain in the hospital for 4 to 6 weeks after the transplant, and will be discharged for outpatient treatment when the study doctors deem it appropriate.
* Patients will continue on medications at home to lower the risk of complications and infections, and will visit the NIH clinic regularly for the first 6 months after the transplant, and then less often for at least 5 years afterward.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.