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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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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

Spots Global Cancer Trial Database for childhood small noncleaved cell lymphoma