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David F McDermott, MD

David E Avigan, MD

The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.

Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders

Amgen

Beth Israel Deaconess Medical Center

Associate Professor of Medicine

Syndrome

Hematologic Neoplasms

Preleukemia

Myelodysplastic Syndromes

Leukemia, Lymphoid

Precancerous Conditions

Busulfan

Busulfan AUC Level 1: 6000 +/- 600 uM-min

Fludarabine 40mg/m2 IV over 1 hour

Busulfan AUC Level 2: 7500 +/- 750 uM-min

Fludarabine 40mg/m2 IV over 1 hour

AUC Level 3: 9000 +/- 900 uM-min

Fludarabine 40mg/m2 IV over 1 hour

Bu IV (BusulfexR) over 3 hours on days -6, -5, -4, and -3. Day -6 and -5 doses for patients on Level 1 will be 170mg/m2. This dose is based on the dose used by DeLima (2004) adjusted proportionately to achieve an AUC of 6000uM-min. Subsequent daily doses for patients on Level 1 will be adjusted to achieve an average AUC of 6000uM-min.

Day -6 and -5 doses for patients on Level 2 will be based on the mean dose required on Level 1 to achieve target AUC then adjusted proportionally for new target AUC.

Subsequent daily doses will be adjusted to achieve target AUCs.

Fludarabine 40mg/m2 IV over 1 hour on days -6, -5, -4, and -3

Teresa Field, PhD, MD

Janelle Perkins, PharmD

Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6, -5, -4, and -3. Daily treatment doses will be adjusted to achieve target area under the plasma concentration time curve (AUC). Day 0 is the day of hematopoietic progenitor cell reinfusion. Supportive care will be based on institutional guidelines. Blood samples will be collected for dose modification based on the AUC levels. Dose escalation will proceed to determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit of higher doses of busulfan.

Patients will receive anti-seizure prophylaxis beginning on day -7. Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6, -5, -4, and -3. Daily treatment doses will be adjusted to achieve target AUCs (area under the plasma concentration time curve). Day 0 is the day of hematopoietic progenitor cell reinfusion.

Supportive care will be based on institutional guidelines. In an effort to prevent hepatotoxicity, ursodiol will be given to patients. During chemotherapy patients will not receive concurrent metronidazole, itraconazole, or be given acetaminophen.

Blood samples will be collected at specific times after Dose 1 and Dose 4 and dose modification will be determined or based on the desired AUC levels. Doses 3 and/or 4 will be adjusted to achieve an average daily Busulfan AUC over the 4 treatment days.

Dose escalation will proceed through 3 dose levels to determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit of higher doses of busulfan.

Graft assessment, processing, and characterization will be done as per institutional guidelines. Donor-recipient chimerism (two genetically distinct types of blood cells) will be characterized by samples obtained pre-transplant and on days 30+/- 7, 90+/-7 and 360+/-30 post-transplant.

Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)

Busulfan Dose Escalation Study Based on AUC in the Setting of Busulfan/Fludarabine Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation (HCT)

The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.

The number of subjects with severe VOD / SOS; severity staged according to criteria set forth by McDonald G.B., Hinds M.S., Fisher L.D., et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118:255-267. Assessed within the first 100 days post transplant.

H. Lee Moffitt Cancer Center and Research Institute

Anticipated "other than serious" Allogeneic Hematopoietic Cell Transplantation (HCT) adverse events were not tabulated.

Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min

AUC Level 1

Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min

AUC Level 2

Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min

AUC Level 3

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Teresa Field

Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour

AUC 6000

Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour

AUC 7500

Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour

AUC 9000

Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS)

Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)

Non-relapse Mortality

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Kidney Diseases

Kidney Failure, Chronic

Renal Insufficiency

Graft vs Host Disease

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Insufficiency, Chronic

Homologous Wasting Disease

Combined bone marrow and kidney transplant

Thomas Spitzer, MD

A. Benedict Cosimi, MD

The purpose of this study is to determine whether a combined bone marrow and kidney transplant will be effective in treating stage II or greater multiple myeloma and associated kidney failure. This study will determine whether transplant rejection and the need for immunosuppressive drugs are decreased with this combined transplant approach.

In very limited human testing, a combined kidney and bone marrow transplant appears to be safe and effective in treating multiple myeloma and associated kidney failure. This study will evaluate this approach in 10 patients with kidney failure due to or in association with stage II or greater multiple myeloma. Treatment prior to transplant will include cyclophosphamide, ATGAM (a lymphocyte-specific immunosuppressant), local radiation to the thymus, and cyclosporine (an immunosuppressive drug).

An infusion of donor bone marrow and a kidney graft from a closely matched, related donor will be transplanted simultaneously. An additional infusion of donor white blood cells may be administered between day 45 and 74 after transplant in an effort to eliminate any remaining cancer cells. Patients will remain on cyclosporine for a defined period of time. The cyclosporine doses will be slowly decreased and stopped if graft rejection and graft-versus-host disease do not occur.

Each participant will be involved in the study for 3 years; this includes the intervention phase (time from initial screening at approximately 7 days before transplant through 100 days after the transplant) and continued follow-up visits for at least 2 years following the transplant.

Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure

Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure

Immune Tolerance Network (ITN)

National Institute of Allergy and Infectious Diseases (NIAID)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders	NCT00636909	AML ALL CML Chronic Pha... CLL MDS RELAPSED NON-HO... APLASTIC ANEMIA MULTIPLE MYELOM... MYELOPROLIFERAT...	Cyclophosphamid... fludarabine cyclosporine methotrexate G-CSF	- 65 Years	Beth Israel Deaconess Medical Center
Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)	NCT00361140	Myelodysplastic... Myeloproliferat... Leukemia, Lymph... Myeloma Lymphoma	Busulfan Fludarabine	16 Years - 65 Years	H. Lee Moffitt Cancer Center and Research Institute
Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)	NCT00361140	Myelodysplastic... Myeloproliferat... Leukemia, Lymph... Myeloma Lymphoma	Busulfan Fludarabine	16 Years - 65 Years	H. Lee Moffitt Cancer Center and Research Institute
Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure	NCT00062621	Kidney Failure,... Multiple Myelom...	Combined bone m...	18 Years - 65 Years	National Institute of Allergy and Infectious Diseases (NIAID)

Spots Global Cancer Trial Database for chimerism

Every month we try and update this database with for chimerism 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 chimerism

Every month we try and update this database with for chimerism 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 chimerism 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.