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Childhood Acute Lymphoblastic Leukemia

cognitive assessment

management of therapy complications

psychosocial assessment and care

quality-of-life assessment

Jean E. Sanders, MD

RATIONALE: Studying quality of life in cancer survivors may help determine the long-term effects of hematologic cancer and may help improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial is studying the quality of life of adult cancer survivors who have undergone a previous bone marrow or peripheral stem cell transplant for a childhood hematologic cancer.

OBJECTIVES:

* Determine the extent to which adult cancer survivors who have undergone prior bone marrow or peripheral blood stem cell transplantation for a pediatric hematologic malignancy require ongoing health care and whether these needs change with increasing time after transplantation.
* Correlate physical capabilities, body image, physical limitations, including sexuality issues which alter or influence lifestyle, with time after transplantation in these patients.
* Determine whether cognitive abilities relative to memory and neurobehavioral ratings change with increasing time after transplantation in these patients.
* Correlate social and relationship abilities with length of time after transplantation in these patients.

OUTLINE: Patients and siblings complete a self-report quality of life questionnaire, including outcome assessments of neuroendocrine function, cognitive abilities, physical capability, and psychosocial behavior.

PROJECTED ACCRUAL: Approximately 750 patients (375 adult cancer survivors \[case group\] and 375 siblings \[control group\]) will be accrued for this study within 7 years.

Quality of Life of Adult Cancer Survivors Who Have Undergone a Previous Bone Marrow or Peripheral Stem Cell Transplant for a Childhood Hematologic Cancer

The Quality of Life of Adult Survivors Who Received a Marrow Transplant as a Child

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Lymphoma, Non-Hodgkin

Anemia

Cytopenia

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Leukemia, Myeloid, Chronic-Phase

Myeloproliferative Disorders

Anemia, Refractory, with Excess of Blasts

Anemia, Refractory

Leukemia, Myeloid, Accelerated Phase

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Blast Crisis

Leukemia, Neutrophilic, Chronic

Mantle Cell Lymphoma

Follicular Lymphoma

Diffuse Large B-Cell Lymphoma

Chronic Myeloproliferative Disorders

Myelodysplastic Syndrome With Excess Blasts

Lymphoma, Large-cell, Immunoblastic

Chronic Neutrophilic Leukemia

Patients receiving umbilical cord blood transplantation.

The graft will be given by slow injection into each posterior iliac crest.

umbilical cord blood transplantation

John E. Wagner, MD

Rationale: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor's umbilical cord blood are injected into the patient's bone marrow they may help make stem cells, red blood cells, white blood cells, and platelets.

Purpose: This phase I/II trial is studying the side effects of donor umbilical cord blood transplant when given directly into the bone marrow and to see how well it works in treating patients with hematologic cancer.

Objectives:

Primary

* Determine the safety, in terms of infusional toxicity, of myeloablative unrelated donor double-unit umbilical cord blood (UCB) transplantation via intra-bone marrow injection (IBMI) in patients with advanced or high-risk hematologic malignancy.
* Determine whether treatment with this regimen improves the time to neutrophil engraftment (compared to historical controls) in these patients.

Secondary

* Determine the incidence of sustained donor engraftment in patients treated with this regimen.
* Determine the relative contribution of each UCB unit to initial and sustained donor engraftment in these patients.
* Determine the incidence of grade II-IV and grade III-IV acute graft-vs-host disease (GVHD) and chronic GVHD in patients treated with this regimen.
* Determine the incidence of day 100 and 180 transplant-related mortality in patients treated with this regimen.
* Determine the probability of survival at 100 days and 1 year post-transplantation in these patients.

Outline: This is a nonrandomized study.

Patients receive a myeloablative conditioning regimen. Patients also receive immunosuppression, growth factor, and supportive care as in protocol MT2005-10 (NCT00309842).

Patients receive 2 units of donor umbilical cord blood (UCB) by intra-bone marrow injection (IBMI) over 10 minutes each on day 0. If the IBMI procedure is not possible, then the UCB units are given intravenously (IV.)

After completion of study therapy, patients are followed periodically for 5 years.

Projected Accrual: A total of 36 patients will be accrued for this study.

Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer

A Phase I/II Study of Double Unit Umbilical Cord Blood (UCB) Transplantation Utilizing Graft Administration Via Intra-Bone Marrow Injection (Companion Protocol to MT2000-25)

Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.

Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.

Number of patients who received both cord blood units and achieved sustained donor engraftment

Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.

Number of patients who were deceased at days 100 and 180 from any cause other than relapse.

Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.

Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.

Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.

Masonic Cancer Center, University of Minnesota

Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.

Umbilical Cord Blood Transplant Patients

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

This study was terminated early based on interim statistical analysis that indicated time to engraftment will not be improved compared to historical controls. While safe, lack of faster marrow recovery supports early discontinuation.

John E. Wagner, M.D.

Median Number of Days to Neutrophil Engraftment

Number of Patients Achieving Neutrophil Recovery

1 patient was not evaluable due to graft failure

Number of Patients With Evidence of Engraftment.

2 patients were not graded for acute GVHD due to graft failure.

Number of Patients With Acute Graft-versus-host Disease (GVHD)

Number of Patients With Transplant-related Mortality (TRM)

Number of Patients Surviving at Day 100 and 1 Year.

2 patients were not yet graded for acute gvhd

Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)

Only 7 patients were at risk for chronic GVHD

Number of Patients With Chronic Graft-versus-host Disease (GVHD).

Overall Study

Heart and Blood Diseases

Infections

Recurrence

Leukemia, Myelomonocytic, Chronic

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, B-Cell, Marginal Zone

Leukemia, Prolymphocytic

Primary Myelofibrosis

Burkitt Lymphoma

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Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Lymphocytic Leukemia

Marginal Zone Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Dermatologic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Cyclosporine

Cyclosporins

Lenograstim

Mycophenolic Acid

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Calcineurin Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.

All patients will receive G-CSF 5 mcg/kg/day intravenously(IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10\^9/L for three consecutive days.

filgrastim

Cyclophosphamide to be administered with high volume fluid flush and mesna (MT(S) 9006) at 10:00am, or per institutional routine, on days-7 and -6 after fludarabine. Cyclophosphamide 60mg/kg/day intravenous (IV) x 2 days, total dose 120 mg/kg (days -7 and -6) Dosing is calculated based on Actual BodyWeight (ABW) unless ABW \> 30 kg above Ideal BodyWeight (IBW), in which case the dose should be computed using adjusted body weight.

cyclophosphamide

Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of \> 200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children \< 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.

cyclosporine

Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -8 to -6);

fludarabine phosphate

All patients will begin mycophenolate mofetil (MMF) on day -3. Patients ≥ 40 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses (every 12 or 8 hours).

Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg three times a day.

mycophenolate mofetil

The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.

The recommended TBI is 165 cGy given twice daily for a total dose of 1320 cGy (days -4 to -1).

total-body irradiation

Claudio G. Brunstein, MD, PhD

RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer.

OBJECTIVES:

Primary

* Determine the 1-year survival of patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine, cyclophosphamide, and fractionated total-body irradiation.

Secondary

* Determine the incidence of transplant-related mortality at 6 months after UCBT.
* Evaluate the pattern of chimerism after double UCBT.
* Determine the incidence of neutrophil engraftment at day 42 after UCBT.
* Determine the incidence of platelet engraftment at 6 months after UCBT.
* Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT.
* Determine the incidence of chronic GVHD at 1 year after UCBT.
* Determine the disease-free survival at 1 and 2 years after UCBT.
* Determine the incidence of relapse at 1 year after UCBT.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

* Preparative Regimen: Patients receive fludarabine IV over 1 hour on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients also undergo total-body irradiation twice daily on days -4 to -1.
* Umbilical Cord Blood Transplantation (UCBT): Patients undergo 1 or 2 units of UCBT on day 0. Patients receive filgrastim (G-CSF) IV once daily beginning on day 1 and continuing until blood counts recover.
* Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours 2 or 3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. Patients also receive mycophenolate mofetil IV or orally 2 or 3 times a day beginning on day -3 and continuing until day 30 or 7 days after engraftment in the absence of acute GVHD.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

Transplantation of Unrelated Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen

Number of patients alive at 1 year after transplant.

Determine the incidence of transplant-related mortality at 6 months after UCBT

Determine the incidence of platelet engraftment (platelet recovery \>50,000/uL) at 6 months after UCBT.

Determine the incidence of neutrophil engraftment at day 42 after UCBT Patients diagnosed with graft failure (failure of absolute neutrophil count ANC \> 5 x 10\^8/L of donor origin by day +42)

Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD.

Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Determine the incidence of chronic GVHD at 1 year after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria.

Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality of Life of Adult Cancer Survivors Who Have Undergone a Previous Bone Marrow or Peripheral Stem Cell Transplant for a Childhood Hematologic Cancer	NCT00126477	Leukemia Lymphoma Myelodysplastic... Quality of Life	cognitive asses... management of t... psychosocial as... quality-of-life...	18 Years -	Fred Hutchinson Cancer Center
Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer	NCT00295880	Myeloproliferat... Leukemia Lymphoma Myelodysplastic...	umbilical cord ...	12 Years - 45 Years	Masonic Cancer Center, University of Minnesota
Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases	NCT00309842	Acute Myeloid L... Acute Lymphocyt... Chronic Myeloge... Myelofibrosis MDS Refractory Anem... Chronic Lymphoc... Prolymphocytic ... Non-Hodgkin's L... Leukemia Lymphoma Multiple Myelom... Myelodysplastic...	filgrastim cyclophosphamid... cyclosporine fludarabine pho... mycophenolate m... umbilical cord ... total-body irra...	- 55 Years	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for childhood large cell lymphoma