Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Neoplasm Metastasis

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Leukemia, Myeloid

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Decitabine

Antimetabolites

Enzyme Inhibitors

Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.

Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.

Azacitidine (AZC)

Quality-of-Life Assessment

Bart L. Scott

This randomized clinical trial studies different chemotherapies in treating patients with myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells, and may prevent the myelodysplastic syndrome from coming back after the transplant. 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.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm A: Patients receive decitabine or azacitidine intravenously (IV) or subcutaneously (SC) for 7 days. Treatment repeats every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.

Arm B: Patients receive induction-like chemotherapy per standard of care or per experimental protocol. This study does not require a specific chemotherapy regimen for Arm B.

After completion of study treatment, patients are followed up for 18 months.

Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant

Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)

18-month failure-free survival (failure defined as death or relapse).

The European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) (version 3) is a 30-item cancer-specific questionnaire for measuring the health-related quality of life (QOL) in cancer patients. It includes five functioning scales (physical, PF; role, RF; cognitive, CF; emotional, EF; and social, SF), three symptom scales (fatigue, FA; pain, PA; and nausea and vomiting, NV), a global health status/QOL scale (GL), and six single items (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial impact of the disease and treatment). All items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome; with the exception of two items in the GL scale, which use 7-point scales (1=very poor to 7=excellent) lower scores representing a worse outcome and higher score representing a better outcome.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire High Dose Chemotherapy (EORTC QLQ-HDC29) is a treatment-specific quality of life questionnaire that addresses treatment specific side effects as well as emotional, social, and family issues for patients treated with high dose regimens and HCT. The QLQ-HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 single-items; all items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome with the exception of question 47 and 52 being the a higher score resulting in a better outcome and lower score a worse outcome.

The total length of follow-up will be 18 months from the start of treatment (day 1). Four categories were added for participants alive 18 months from start of treatment (day 1) 1) Participants alive after 18 months from start of treatment who received hematopoietic cell transplantation (HCT); 2) Participants alive after 18months from start of treatment who did not receive HCT.; 3) Participants deceased after 18 months from start of treatment who received HCT; 4) Participants deceased after 18 months from start of treatment who did not receive HCT.

To compare which of the two, intensive chemotherapy versus hypomethylating agent-based therapy, have a factor of relapse post hematopoietic cell transplantation (HCT).

Frequency at which the participants received a hematopoietic cell transplantation (HCT)

Fred Hutchinson Cancer Center

Professor

Serious AEs and Other AEs were not collected for this study. Only All-Cause Mortality was monitored.

Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.

Azacitidine (AZC): Given IV or SC

Decitabine: Given IV or SC

Quality-of-Life Assessment: Ancillary studies

Arm A (Decitabine or Azacitidine)

Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.

Quality-of-Life Assessment: Ancillary studies

Arm B (Induction-like Chemotherapy Regimen)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Eligible patients will be randomized in a 1:1 fashion. The primary outcome will be analyzed on an intention-to-treat basis.

Bart Lee Scott M.D.

Number of subjects enrolled and randomized in each arm.

Failure-free Survival (Failure Defined as Death or Relapse)

EORTCQLQ-C30 at Screening 1. Do you have any trouble doing strenuous activities?

EORTCQLQ-C30 at Pre-Transplant 1. Do you have any trouble doing strenuous activities?

EORTCQLQ-C30 at post-transplant 1. Do you have any trouble doing strenuous activities?

EORTCQLQ-C30 at Screening 2. Do you have any trouble taking a long walk?

EORTCQLQ-C30 at Pre-transplant 2. Do you have any trouble taking a long walk?

EORTCQLQ-C30 at Post-transplant 2. Do you have any trouble taking a long walk?

EORTCQLQ-C30 at Screening 3. Do you have any trouble taking a short walk outside of the house?

EORTCQLQ-C30 at Pre-transplant 3. Do you have any trouble taking a short walk outside of the house?

EORTCQLQ-C30 at Post-transplant 3.Do you have any trouble taking a short walk outside of the house?

EORTCQLQ-C30 at Screening 4. Do you need to stay in bed or a chair during the day?

EORTCQLQ-C30 at Pre transplant 4. Do you need to stay in bed or a chair during the day?

EORTCQLQ-C30 at Post-transplant 4. Do you need to stay in bed or a chair during the day?

EORTCQLQ-C30 at Screening 5. Do you need help with eating, dressing, washing yourself?

EORTCQLQ-C30 at Pre-transplant 5. Do you need help with eating, dressing, washing yourself?

EORTCQLQ-C30 at Post-transplant 5. Do you need help with eating, dressing, washing yourself?

EORTCQLQ-C30 at Screening 6. Were you limited in doing either your work or other daily activities?

EORTCQLQ-C30 Pre-transplant 6.Were you limited in doing either your work or other daily activities?

EORTCQLQ-C30 Post-Transplant 6.Were you limited in doing either your work/ other daily activities?

EORTCQLQ-C30 Screening 7.Were you limited in pursing your hobbies or other leisure time activities?

EORTCQLQ-C30 Pre-transplant 7.Were you limited in pursing your hobbies/other leisure activities?

EORTCQLQ-C30 Post-transplant 7.Were you limited in pursing your hobbies/other leisure activities?

EORTCQLQ-C30 Screening 8. Were you short of breath?

EORTCQLQ-C30 Pre-transplant 8. Were you short of breath?

EORTCQLQ-C30 Post-transplant 8. Were you short of breath?

EORTCQLQ-C30 Screening 9. Have you had pain?

EORTCQLQ-C30 Pre-transplant 9. Have you had pain?

EORTCQLQ-C30 Post-transplant 9. Have you had pain?

EORTCQLQ-C30 Screening 10. Did you need to rest?

EORTCQLQ-C30 Pre-transplant 10. Did you need to rest?

EORTCQLQ-C30 Post-transplant 10. Did you need to rest?

EORTCQLQ-C30 Screening 11. Have you had trouble sleeping?

EORTCQLQ-C30 Pre-transplant 11. Have you had trouble sleeping?

EORTCQLQ-C30 Post-transplant 11. Have you had trouble sleeping?

EORTCQLQ-C30 Screening 12. Have you felt weak?

EORTCQLQ-C30 Pre-transplant 12. Have you felt weak?

EORTCQLQ-C30 Post-transplant 12. Have you felt weak?

EORTCQLQ-C30 Screening 13. Have you lacked appetite?

EORTCQLQ-C30 Pre-transplant 13. Have you lacked appetite?

EORTCQLQ-C30 Post-transplant 13. Have you lacked appetite?

EORTCQLQ-C30 Screening 14. Have you felt nauseated?

EORTCQLQ-C30 Pre-transplant 14. Have you felt nauseated?

EORTCQLQ-C30 Post-transplant 14. Have you felt nauseated?

EORTCQLQ-C30 Screening 15. Have you vomited?

EORTCQLQ-C30 Pre-transplant 15. Have you vomited?

EORTCQLQ-C30 Post-transplant 15. Have you vomited?

EORTCQLQ-C30 Screening 16. Have you been constipated?

EORTCQLQ-C30 Pre-transplant 16. Have you been constipated?

EORTCQLQ-C30 Post-transplant 16. Have you been constipated?

EORTCQLQ-C30 Screening 17. Have you had diarrhea?

EORTCQLQ-C30 Pre-transplant 17. Have you had diarrhea?

EORTCQLQ-C30 Post-transplant 17. Have you had diarrhea?

EORTCQLQ-C30 Screening 18. Were you tired?

EORTCQLQ-C30 Pre-transplant 18. Were you tired?

EORTCQLQ-C30 Post-transplant 18. Were you tired?

EORTCQLQ-C30 Screening 19. Did pain interfere with your daily activities?

EORTCQLQ-C30 Pre-transplant 19. Did pain interfere with your daily activities?

EORTCQLQ-C30 Post-transplant 19. Did pain interfere with your daily activities?

EORTCQLQ-C30 Screening 20. Difficulty concentrating on things like reading a or watching TV?

EORTCQLQ-C30 Pre-transplant 20. Difficulty concentrating on things like reading a or watching TV?

EORTCQLQ-C30 Post-transplant 20. Difficulty concentrating on things like reading a or watching TV?

EORTCQLQ-C30 Screening 21. Did you feel tense?

EORTCQLQ-C30 pre-transplant 21. Did you feel tense?

EORTCQLQ-C30 Post-transplant 21. Did you feel tense?

EORTCQLQ-C30 Screening 22. Did you worry?

EORTCQLQ-C30 Pre-transplant 22. Did you worry?

EORTCQLQ-C30 Post-transplant 22. Did you worry?

EORTCQLQ-C30 Screening 23. Did you feel irritable?

EORTCQLQ-C30 Pre-Transplant 23. Did you feel irritable?

EORTCQLQ-C30 Post-Transplant 23. Did you feel irritable?

EORTCQLQ-C30 Screening 24. Did you feel depressed?

EORTCQLQ-C30 Pre-Transplant 24. Did you feel depressed?

EORTCQLQ-C30 Post-Transplant 24. Did you feel depressed?

EORTCQLQ-C30 Screening 25. Have you had difficulty remembering things?

EORTCQLQ-C30 Pre-transplant 25. Have you had difficulty remembering things?

EORTCQLQ-C30 Post-transplant 25. Have you had difficulty remembering things?

EORTCQLQ-C30 Screening 26. Has your physical condition/medical treatment interfere with family?

EORTCQLQ-C30 Pre-transplant 26.Has your physical condition/medical treatment interfere w/family?

EORTCQLQ-C30 Post-transplant 26.Has your physical condition/medical treatment interfere w/family?

EORTCQLQ-C30 Screening 27.Has your physical condition/medical treatment interfere w/social life?

EORTCQLQ-C30Pre-transplant 27.Has your physical condition/medical treatment interfere w/social life?

EORTCQLQ-C30 Post-trans 27.Has your physical condition/medical treatment interfere w/social life?

EORTCQLQ-C30 Screening 28.Physical condition/medical treatment caused financial difficulties?

EORTCQLQ-C30 Pre-transplant 28.Physical condition/medical treatment caused financial difficulties?

EORTCQLQ-C30 Posttransplant 28.Physical condition/medical treatment caused financial difficulties?

EORTCQLQ-C30 Screening 29.How would you rate your overall health during the past week?

EORTCQLQ-C30 Pre-transplant 29.How would you rate your overall health during the past week?

EORTCQLQ-C30 Post-transplant 29.How would you rate your overall health during the past week?

EORTCQLQ-C30 Screening 30. How would you rate your overall quality of life during the past week?

EORTCQLQ-C30 Pretransplant 30.How would you rate your overall quality of life during the past week?

EORTCQLQ-C30 Posttransplant 30.How would you rate your overall QoL during the past week?

Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.

Azacitidine (AZC): Given IV or SC

Decitabine: Given IV or SC

Arm A (Azacitidine or Decitabine)

Arm B (Induction Like Chemotherapy)

The QLQ-C30 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 22 subjects submitted EORTC QLQ-C30 at screening; 14 subjects completed EORTC QLQ-C30 at pre-transplant and 10 subjects post-transplant. For Arm B (induction chemo) 25 subjects submitted EORTC QLQ-C30 at screening; 13 subjects completed QLQ-C30 at pre-transplant and 10 subjects post-transplant. Scores for each question and timepoints were averaged to obtain mean.

Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.

QLQ-HDC 29 Pre-HSCT 31. Have you had soreness in your mouth?

QLQ-HDC 29 Post-HSCT 31. Have you had soreness in your mouth?

QLQ-HDC 29 Pre-HSCT 32. Have you had a dry mouth?

QLQ-HDC 29 Post-HSCT 32. Have you had a dry mouth?

QLQ-HDC 29 Pre-HSCT 33. Have you had trouble swallowing?

QLQ-HDC 29 Post-HSCT 33. Have you had trouble swallowing?

QLQ-HDC 29 Pre-HSCT 34. Did food and drink taste different from usual?

QLQ-HDC 29 Post-HSCT 34. Did food and drink taste different from usual?

QLQ-HDC 29 Pre-HSCT 35. Have you had abdominal pains or cramps?

QLQ-HDC 29 Post-HSCT 35. Have you had abdominal pains or cramps?

QLQ-HDC 29 Pre-HSCT 36. Have you had skin problems?

QLQ-HDC 29 Post-HSCT 36. Have you had skin problems?

QLQ-HDC 29 Pre-HSCT 37. Have you been upset by how the treatment has affected your hair?

QLQ-HDC 29 Post-HSCT 37. Have you been upset by how the treatment has affected your hair?

QLQ-HDC 29 Pre-HSCT 38. Have you worried about your weight being too low?

QLQ-HDC 29 Post-HSCT 38. Have you worried about your weight being too low?

QLQ-HDC 29 Pre-HSCT 39. Have you had fevers or chills?

QLQ-HDC 29 Post-HSCT 39. Have you had fevers or chills?

QLQ-HDC 29 Pre-HSCT 40. Did you urinate frequently?

QLQ-HDC 29 Post-HSCT 40. Did you urinate frequently?

QLQ-HDC 29 Pre-HSCT 41. Have you had aches or pains in your bones?

QLQ-HDC 29 Post-HSCT 41. Have you had aches or pains in your bones?

QLQ-HDC 29 Pre-HSCT 42. Have you found it difficult to finish things you started?

QLQ-HDC 29 Post-HSCT 42. Have you found it difficult to finish things you started?

QLQ-HDC 29 Pre-HSCT 43. Did you worry about the results of examinations and tests?

QLQ-HDC 29 Post-HSCT 43. Did you worry about the results of examinations and tests?

QLQ-HDC 29 Pre-HSCT 44. Have you had trouble coping with the hospital stay?

QLQ-HDC 29 Post-HSCT 44. Have you had trouble coping with the hospital stay?

QLQ-HDC 29 Pre-HSCT 45. Has the isolation in the hospital troubled you?

QLQ-HDC 29 Post-HSCT 45. Has the isolation in the hospital troubled you?

QLQ-HDC 29 Pre-HSCT 46. Have you worried that the blood counts may not recover?

QLQ-HDC 29 Post-HSCT 46. Have you worried that the blood counts may not recover?

QLQ-HDC 29 Pre-HSCT 47. How satisfied were you with the preparation for your treatment?

QLQ-HDC 29 Post-HSCT 47. How satisfied were you with the preparation for your treatment?

QLQ-HDC 29 Pre-HSCT 48. Have you felt isolated from those close to you (family, friends)?

QLQ-HDC 29 Post-HSCT 48. Have you felt isolated from those close to you (family, friends)?

QLQ-HDC 29 Pre-HSCT49.Have you been concerned about disruption to your family life due to treatment?

QLQ-HDC29Post HSCT 49.Have you been concerned about disruption to your family life due to treatment?

QLQ-HDC29 Pre HSCT 50. How distressing do you think your illness/treatment has been to those close?

QLQ-HDC29 Post-HSCT 50. How distressing do you think your illness/treatment has been to those close?

The QLQ-HDC29 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 14 subjects submitted EORTC QLQ-HDC29 at pre-HCST and 10 subjects post-HSCT. For Arm B (induction chemo) 13 subjects submitted QLQ-HDC29 at pre-HSCT and 10 subjects post-HSCT. Scores for each question and timepoints were averaged to obtain mean. However, there are some questions were subjects noted N/A and these answered were subtracted from the number analyzed.

Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.

Spots Global Cancer Trial Database for Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant

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Study Description

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