Neoplasms

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Blood and Lymph Conditions

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All Conditions

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Multiple Myeloma

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Lymphoma

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Leukemia, Lymphoid

Hematologic Neoplasms

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Graft vs Host Disease

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Homologous Wasting Disease

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Fludarabine

Fludarabine phosphate

Rituximab

Melphalan

Antineoplastic Agents, Immunological

Immunologic Factors

Antimetabolites

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion

30 mg/m\^2 by vein for 4 Days (Day -10 through Day -7).

Umbilical Cord Blood

375 mg/m\^2 by vein once weekly (Days -7, -1, +7, +14) for 4 Weeks (if appropriate).

Peripheral Blood Stem Cell Infusion

Partow Kebriaei, MD

The goal of this clinical research study is to learn if giving umbilical cord blood along with standard stem cells after high-dose chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied.

Cord blood is a source of blood-forming cells that can be used for transplantation. Cord blood cells are taken from the umbilical cords of women who have given birth, and who have volunteered to donate their umbilical cord. Researchers hope that using cord blood before a stem cell transplant will help to reduce the risk of graft-versus-host-disease (GVHD). GVHD occurs when donor cells attack the cells of the person receiving the transplant.

If you are found to be eligible to take part in this study, you will receive chemotherapy for 5 days. You will receive fludarabine over about 30 minutes through a needle in your vein on Days 1-4. You will receive melphalan through a needle in your vein over about 30 minutes on Day 5.

On Day 7, you will receive the cord blood cells through a needle in your vein over about 30 minutes.

On Day 12, you will receive blood stem cells through a needle in your vein over 30-60 minutes. The stem cells you receive will be from a stem cell donor whose human leukocyte antigen (HLA- proteins on cells) type matches yours.

If appropriate for the disease, you will also receive rituximab about once weekly for 4 weeks, beginning on the day you receive melphalan. Rituximab is given though a needle in your vein over 2-3 hours.

You will receive the drugs tacrolimus and methotrexate to lower the risk of GVHD. Tacrolimus will be given through a needle in your vein non-stop for 2 weeks, starting 12 hours after the stem cell transplant. After the first 2 weeks, you will continue to receive tacrolimus by mouth, for at least 3 months. You will receive methotrexate though a needle in your vein over 30 minutes, starting 1 day after the stem cell transplant, for a total of 3 doses over the first 6 days after the stem cell transplant.

You will receive the G-CSF (granulocyte-colony stimulating factor) to help you blood cell counts recover. G-CSF will be given as an injection under the skin, beginning 1 week after the stem cell transplant. You will continue to receive G-CSF once a day until your blood cell counts reach a certain high enough level.

You will need to stay in the hospital for about 4 weeks beginning on Day 1. While you are in the hospital, blood (about 2 teaspoons) will be drawn every day for routine tests.

After you leave the hospital, you will return to the hospital for visits 2-3 times a week for at least 100 days after the transplant. During these visits, you will have a physical exam and blood (about 2 teaspoons) will be drawn for routine tests.

You will be asked to come back to the clinic for follow-up visits at 3, 6, 9 and 12 months after your transplant for routine safety testing. This will include a physical exam, a bone marrow biopsy, and blood (about 2 teaspoons) will be drawn for routine testing.

You will be considered off-study after the 12-month follow-up visit.

This is an investigational study. The stem cell transplant, the umbilical cord transplant, and all drugs used on this study are FDA approved. The use of umbilical cord blood and stem cells together is investigational. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Cellular Therapy With Cord Blood Cells

Use of Umbilical Cord Blood Cell in the Preparative Regimen of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 \* 10\^9/L; assessed from baseline to 100 days post-engraftment.

M.D. Anderson Cancer Center

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Partow Kebriaei

Fludarabine 30 mg/m\^2 given daily for four days. Melphalan 140 mg/m\^2 given for one day. Umbilical Cord Blood Unit given on one day.

Fludarabine + Melphalan + Umbilical Cord Blood Unit

Number of Participants With Engraftment

Overall Study

Anti-Infective Agents

Gemcitabine

Vinorelbine

Doxorubicin

Liposomal doxorubicin

Pembrolizumab

Immune Checkpoint Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Part 1: Patients will receive 2-4 cycles of pembrolizumab plus GVD

Part 2: up to 40 patients will be enrolled onto an expansion cohort. On the expansion, patients who achieve CR to 4 cycles of pembro-GVD will receive 13 cycles of pembrolizumab maintenance (instead of HDT/ASCT).

Age 10-17: 2mg/kg (cap at 200mg), Age ≥ 18: 200 mg (flat) ,Day 1 of each 3 week cycle IV infusion 2-4 cycles (pre-ASCT)

pembrolizumab

1000mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

gemcitabine

20mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

vinorelbine

15mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

liposomal doxorubicin

Stem cell mobilization and collection will be performed as per standard MSKCC guidelines after 2-4 cycles of pembrolizumab-GVD.

Stem cell mobilization and collection

Alison Moskowitz, MD

Heiko Schoder, MD

Craig Moskowitz, MD

The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.

This is a phase II study evaluating pembrolizumab plus gemcitabine, vinorelbine, liposomal doxorubicin (GVD) in transplant eligible patients with relapsed or refractory Hodgkin lymphoma following failure of 1-line of multi-agent chemotherapy.

Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Response to pembrolizumab-GVD will be assessed using the RECIL criteria.

Only patients who receive the Pembrolizumab maintenance regime will be considered evaluable for 2-year PFS and OS rates.

Merck Sharp & Dohme LLC

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cellular Therapy With Cord Blood Cells	NCT00427557	Multiple Myelom... Leukemia Lymphoma	Fludarabine Melphalan Umbilical Cord ... Rituximab Peripheral Bloo...	- 80 Years	M.D. Anderson Cancer Center
Cellular Therapy With Cord Blood Cells	NCT00427557	Multiple Myelom... Leukemia Lymphoma	Fludarabine Melphalan Umbilical Cord ... Rituximab Peripheral Bloo...	- 80 Years	M.D. Anderson Cancer Center
Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma	NCT03618550	Hodgkin Lymphom... Relapsed or Ref...	pembrolizumab gemcitabine vinorelbine liposomal doxor... Stem cell mobil...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for gvd

Every month we try and update this database with for gvd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gvd

Every month we try and update this database with for gvd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gvd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.